| 1 |
NCT02978859 |
Recruiting |
MGCD516 in Advanced Liposarcoma and Other Soft Tissue Sarcomas |
- Liposarcoma
- Metastatic Liposarcoma
|
|
Interventional
|
Phase 2 |
- Gary Schwartz
- Mirati Therapeutics Inc.
- Columbia University
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free rate
- Adverse event rate
- Overall response rate
- (and 2 more...)
|
29 |
All |
18 Years and older (Adult, Older Adult) |
NCT02978859 |
AAAQ8661 |
|
November 2016 |
January 2019 |
January 2020 |
December 1, 2016 |
January 10, 2018 |
|
- Massachussetts General Hospital
Boston, Massachusetts, United States - Columbia University Medical Center
New York, New York, United States
|
|
| 2 |
NCT01913652 |
Recruiting |
Ph II Cabazitaxel DD Liposarcoma |
- Dedifferentiated Liposarcoma
|
|
Interventional
|
Phase 2 |
- European Organisation for Research and Treatment of Cancer - EORTC
- Sanofi
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival (PFS)
- Time to progression
- Progression free survival
- (and 5 more...)
|
37 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01913652 |
EORTC-1202
2012-003672-39
cabazL06470 |
|
October 2014 |
February 2019 |
February 2019 |
August 1, 2013 |
July 9, 2018 |
|
- Universitair Ziekenhuis Antwerpen (117)
Antwerpen, Belgium - Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)
Brussels, Belgium - CHU de Dijon - Centre Georges-Francois-Leclerc (229)
Dijon, France - (and 8 more...)
|
|
| 3 |
NCT02606461 |
Recruiting |
Selinexor in Advanced Liposarcoma |
- Dedifferentiated Liposarcoma
|
- Drug: Selinexor
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
- Karyopharm Therapeutics Inc
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Assess and compare Progression-free Survival (PFS) of patients with advanced unresectable DDLS treated with selinexor (60 milligrams [mg]) or placebo.
|
279 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT02606461 |
KCP-330-020
2015-003594-14 |
SEAL |
December 2015 |
November 2019 |
March 2020 |
November 17, 2015 |
February 1, 2019 |
|
- Cedars-Sinai Medical Center
Los Angeles, California, United States - University of California, Los Angeles
Los Angeles, California, United States - Sarcoma Oncology Center
Santa Monica, California, United States - (and 70 more...)
|
|
| 4 |
NCT02106312 |
Recruiting |
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas |
- Myxoid Liposarcoma of Soft Tissue
|
- Radiation: dose reduction of preoperative radiotherapy in MLS
|
Interventional
|
Phase 2 |
- The Netherlands Cancer Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT02106312 |
N10DMY
2588 |
DOREMY |
December 15, 2010 |
December 15, 2019 |
December 15, 2019 |
April 8, 2014 |
August 8, 2018 |
|
- Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Harvard Cancer Center
Boston, Massachusetts, United States - University Hospital Aarhus
Aarhus, Denmark - (and 9 more...)
|
|
| 5 |
NCT02247544 |
Recruiting |
Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma |
- Liposarcoma
- Leiomyosarcoma
|
|
Interventional
|
Phase 2 |
- Italian Sarcoma Group
- Istituto Di Ricerche Farmacologiche Mario Negri
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Growth Modulation Rate
- Objective response (OR) in the overall sample
- Pathological tumour response in the two eligible histological types, in patients undergoing surgery after treatment
- (and 4 more...)
|
95 |
All |
18 Years and older (Adult, Older Adult) |
NCT02247544 |
ISG-STS-TRAB-2012
2012-005428-14 |
TRAVELL |
March 2014 |
January 2019 |
October 2020 |
September 25, 2014 |
November 12, 2018 |
|
- A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy - Istituto Tumori Giovanni Paolo II
Bari, BA, Italy - Azienda Ospedaliera Giovanni Paolo XXIII
Bergamo, BG, Italy - (and 20 more...)
|
|
| 6 |
NCT03361436 |
Recruiting |
Eribulin Mesylate and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery |
- Liposarcoma
- Retroperitoneal Neoplasm
|
- Drug: Eribulin Mesylate
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- (and 3 more...)
|
Interventional
|
Phase 1 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03
- Change in subject-reported quality of life assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
- Objective response rate (ORR) defined as the proportion of subjects who achieved a complete response (disappearance of all target tumors) or a partial response (>= 30% decrease in the sum of the longest diameters of target tumors)
- (and 8 more...)
|
16 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT03361436 |
STUDY00017190
NCI-2017-02120
P30CA069533 |
|
March 19, 2018 |
February 28, 2020 |
February 28, 2022 |
December 4, 2017 |
June 25, 2018 |
|
- OHSU Knight Cancer Institute
Portland, Oregon, United States
|
|
| 7 |
NCT03096912 |
Recruiting |
A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma |
- Liposarcomas, Dedifferentiated
- Liposarcoma - Well Differentiated
- Liposarcoma; Mixed Type
- Soft-Tissue Sarcoma
|
|
Interventional
|
Phase 2 |
- Assaf-Harofeh Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response to therapy as evaluated by RECIST 1.1
- Response to therapy as evaluated by Choi
- Median PFS
- (and 2 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03096912 |
243/16 |
|
July 2016 |
December 2019 |
April 2020 |
March 30, 2017 |
October 25, 2017 |
|
- Assaf Harofeh Medical Center
Be'er Ya'aqov, Israel
|
|
| 8 |
NCT02846987 |
Recruiting |
Study of Abemaciclib in Dedifferentiated Liposarcoma |
- Sarcoma
- Dedifferentiated Liposarcoma
|
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Eli Lilly and Company
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
33 |
All |
18 Years and older (Adult, Older Adult) |
NCT02846987 |
16-376 |
|
July 2016 |
July 2019 |
July 2019 |
July 27, 2016 |
January 7, 2019 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
|
| 9 |
NCT03303885 |
Recruiting |
The FGF/FGFR Signalling Pathway: |
|
|
Observational
|
|
- Centre Hospitalier Universitaire de Nice
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- difference in terms of overall survival: between FGF18 - versus FGF18+
|
250 |
All |
18 Years and older (Adult, Older Adult) |
NCT03303885 |
16-PRTK |
FILIPO |
October 1, 2017 |
October 1, 2019 |
October 1, 2019 |
October 6, 2017 |
November 21, 2018 |
|
- Nice Hospital
Nice, France
|
|
| 10 |
NCT03114527 |
Recruiting |
Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) |
|
- Drug: Ribociclib
- Drug: Everolimus
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Antitumor activity of Ribociclib in combination with Everolimus in advanced LMS or DDL
- Objective response rate (ORR)
- Progression-free survival (PFS)
- (and 2 more...)
|
48 |
All |
18 Years and older (Adult, Older Adult) |
NCT03114527 |
SAR-096
17-1013 |
|
August 8, 2017 |
December 2019 |
December 2019 |
April 14, 2017 |
February 15, 2019 |
|
- Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
|
|
| 11 |
NCT02821507 |
Recruiting |
Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma |
- Conventional Chondrosarcoma
- Myxoid Liposarcoma
- Mesenchymal Chondrosarcoma
- Dedifferentiated Chondrosarcoma
|
- Drug: sirolimus and cyclophosphamide
|
Interventional
|
Phase 2 |
- Leiden University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The time to progression after start of treatment combination treatment of sirolimus and cyclophosphamide
- Comparing pre-treatment tumor material and tumor material taken during treatment using immunohistochemistry to compare activation of the pS6, Bcl-2 and mTor pathway and DNA analysis for taqman analysis to search for hotspot mutations.
- Register adverse events to evaluate the patient safety and tolerability of the sirolimus and cyclophosphamide combination in myxoid liposarcoma and chondrosarcoma
- (and 3 more...)
|
105 |
All |
18 Years and older (Adult, Older Adult) |
NCT02821507 |
COSYMO |
|
June 2014 |
January 2020 |
June 2020 |
July 1, 2016 |
July 11, 2018 |
|
- LUMC
Leiden, Netherlands - Hospital de Sant Pau
Barcelona, Spain - Hospital Val d'Hebron
Barcelona, Spain - (and 4 more...)
|
|
| 12 |
NCT03810976 |
Recruiting
New |
A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma |
|
- Drug: Eribulin, gemcitabine
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- progression free survival
- adverse event
|
37 |
All |
19 Years and older (Adult, Older Adult) |
NCT03810976 |
4-2017-0933 |
|
March 27, 2018 |
March 31, 2020 |
March 31, 2020 |
January 21, 2019 |
January 21, 2019 |
|
- Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
|
|
| 13 |
NCT02992743 |
Recruiting |
A Pilot Study of NY-ESO-1ᶜ²⁵⁹T Cells in Subjects With Advanced Myxoid/ Round Cell Liposarcoma |
|
- Genetic: Autologous genetically modified T Cells, NY-ESO-1ᶜ²⁵⁹T
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
|
- Proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR).
- Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
- Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
- (and 4 more...)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT02992743 |
208469
ADP-0011-007 |
|
December 6, 2016 |
June 26, 2020 |
June 26, 2020 |
December 14, 2016 |
October 16, 2018 |
|
- GSK Investigational Site
Tampa, Florida, United States - GSK Investigational Site
Ann Arbor, Michigan, United States - GSK Investigational Site
Saint Louis, Missouri, United States - (and 2 more...)
|
|
| 14 |
NCT03773510 |
Not yet recruiting |
Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin |
- Leiomyosarcoma
- Liposarcoma
- Synovial Sarcoma
|
- Drug: Trabectedin discontinuation
- Drug: Trabectedin continuation
|
Interventional
|
Phase 3 |
- Italian Sarcoma Group
- PharmaMar
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time secondary resistance to Trabectedin
- Overall Survival
- Incidence of adverse event
- Progression free survival
|
330 |
All |
18 Years and older (Adult, Older Adult) |
NCT03773510 |
ISG TRADITIONS |
TRADITIONS |
February 28, 2019 |
October 1, 2025 |
October 1, 2025 |
December 12, 2018 |
December 12, 2018 |
|
- A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, FC, Italy - Istituto Europeo di Oncologia
Milano, MI, Italy - (and 12 more...)
|
|
| 15 |
NCT03307616 |
Recruiting |
Study of Neoadjuvant Checkpoint Blockade in Patients With Surgically Resectable Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma |
- Systemic Connective Tissue Disorders
|
- Drug: Nivolumab
- Drug: Ipilimumab
- Radiation: Radiation Therapy
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Bristol-Myers Squibb
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic Response
- Immunologic Response
- Change in Immune Infiltrate in Response to Neoadjuvant Nivolumab Monotherapy and Neoadjuvant Nivolumab and Ipilimumab Combination Therapy
- (and 4 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03307616 |
2017-0143
NCI-2018-01031 |
|
October 4, 2017 |
October 2021 |
October 2021 |
October 12, 2017 |
December 25, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 16 |
NCT03190174 |
Recruiting |
Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma |
- Undifferentiated Pleomorphic Sarcoma
- Liposarcoma
- Chondrosarcoma
- (and 2 more...)
|
- Drug: Nab-Rapamycin
- Biological: Nivolumab
|
Interventional
|
Phase 1
Phase 2 |
- Sarcoma Oncology Research Center, LLC
- Aadi, LLC
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose
- Disease control rate
- Progression free survival
- Overall survival
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03190174 |
SOC-1701 |
|
August 24, 2017 |
February 1, 2020 |
April 1, 2020 |
June 16, 2017 |
September 6, 2018 |
|
- Sarcoma Oncology Research Center
Santa Monica, California, United States
|
|
| 17 |
NCT02983539 |
Recruiting |
Detection of Circulating Tumor Cells in Patients With Sarcomas |
- Leiomyosarcoma
- Pleomorphic Liposarcoma
- Synovial Sarcoma
- Liposarcoma
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- progression free survival
|
20 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02983539 |
ACFrance |
CTCS |
October 2015 |
June 2018 |
June 2018 |
December 6, 2016 |
July 2, 2018 |
|
- ACCamargo Cancer Center
Sao Paulo, SP, Brazil
|
|
| 18 |
NCT03450122 |
Recruiting |
Study of Adoptive Immunotherapy Using Autologous CD8+ NY-ESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 For Patients With Sarcoma |
- Malignant Neoplasms of Bone and Articular Cartilage
- Malignant Neoplasms of Mesothelial and Soft Tissue
- Synovial Sarcoma
- Myxoid Liposarcoma
|
- Biological: Modified T Cells
- Drug: Cyclophosphamide
- Biological: IL-2
- (and 2 more...)
|
Interventional
|
Phase 1 |
- M.D. Anderson Cancer Center
- Immune Design
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events of Adoptively Transferred CD8 T Cells Targeting NY-ESO-1+ Tumors Given Alone and in Combination with Antigen-Specific Vaccination
- Functional Persistence of NY-ESO-1-Specific CD8 T-Cells Given Alone and in Combination with Antigen-Specific Vaccination
- Numeric In Vivo Persistence of NY-ESO-1-Specific CD8 T-Cells Given Alone and in Combination with Antigen-Specific Vaccination
- (and 3 more...)
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT03450122 |
2017-0315
NCI-2018-00926 |
|
September 13, 2018 |
December 2019 |
December 2019 |
March 1, 2018 |
January 30, 2019 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 19 |
NCT02357810 |
Recruiting |
Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas |
- Adult Liposarcoma
- Metastatic Liposarcoma
- Metastatic Osteosarcoma
- (and 4 more...)
|
- Drug: Pazopanib Hydrochloride
- Drug: Oral Topotecan Hydrochloride
- Other: Laboratory Biomarker Analysis
|
Interventional
|
Phase 2 |
- Northwestern University
- GlaxoSmithKline
- National Cancer Institute (NCI)
|
Other / Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time from enrollment to progression
- Overall response rate (CR + PR) per RECIST version 1.1
- Clinical benefit (CR+ PR + SD) per RECIST version 1.1
- (and 2 more...)
|
136 |
All |
18 Years and older (Adult, Older Adult) |
NCT02357810 |
NU 14S03
NCI-2014-02583
STU00200112
P30CA060553 |
|
February 2015 |
July 2019 |
June 2020 |
February 6, 2015 |
October 1, 2018 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - Mayo Clinic in Florida
Jacksonville, Florida, United States - Northwestern University
Chicago, Illinois, United States - (and 6 more...)
|
|
| 20 |
NCT03399448 |
Recruiting |
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) |
- Multiple Myeloma
- Melanoma
- Synovial Sarcoma
- Myxoid/Round Cell Liposarcoma
|
- Biological: NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Device: NY-ESO-1 expression testing
|
Interventional
|
Phase 1 |
- University of Pennsylvania
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Determine safety profile of a single infusion of NYCE T cells by monitoring the frequency and severity of adverse events assessed by the National Cancer Institute (NCI) - Common Toxicity Criteria (v4.03)
- Evaluate Manufacturing Feasibility of NYCE T Cells.
- Percentage of patients achieving complete response (CR) before or at Month 6
- (and 4 more...)
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT03399448 |
UPCC# 25416; IRB #826672 |
|
September 5, 2018 |
January 2033 |
January 2033 |
January 16, 2018 |
December 7, 2018 |
|
- University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 21 |
NCT02048371 |
Recruiting |
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes |
- Liposarcoma
- Osteogenic Sarcoma
- Ewing/Ewing-like Sarcoma
- Rhabdomyosarcoma
|
- Drug: Regorafenib
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Sarcoma Alliance for Research through Collaboration
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The progression-free survival (PFS)
- The incidence of reported CTCAE (Common Terminology Criteria for Adverse Events) version 4.03 adverse events
- Overall response rate (ORR)
- Time to tumor progression (TTP)
|
150 |
All |
5 Years and older (Child, Adult, Older Adult) |
NCT02048371 |
SARC024 |
|
July 2014 |
August 2020 |
December 2020 |
January 29, 2014 |
February 11, 2019 |
|
- City of Hope National Medical Center
Duarte, California, United States - Children's Hospital Los Angeles
Los Angeles, California, United States - Sarcoma Oncology Research Center
Santa Monica, California, United States - (and 14 more...)
|
|
| 22 |
NCT03132922 |
Recruiting |
MAGE-A4ᶜ¹º³²T for Multi-Tumor |
- Urinary Bladder Cancer
- Melanoma
- Head and Neck Cancer
- (and 6 more...)
|
- Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with adverse events (AE), including serious adverse events (SAEs).
- Determining dose limiting toxicities (DLT) and optimally tolerated dose range
- Evaluation of persistence of genetically modified T cells.
- (and 8 more...)
|
42 |
All |
18 Years and older (Adult, Older Adult) |
NCT03132922 |
ADP-0044-001 |
|
May 15, 2017 |
September 2020 |
September 2035 |
April 28, 2017 |
February 6, 2019 |
|
- University of Miami
Miami, Florida, United States - Washington University School of Medicine
Saint Louis, Missouri, United States - Roswell Park Cancer Institute
Buffalo, New York, United States - (and 4 more...)
|
|
| 23 |
NCT01710176 |
Recruiting |
Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy |
- Localized High-risk Soft Tissue Sarcomas of the Extremities and Trunk Wall in Adults
|
- Drug: epirubicin 60 mg/m2/day (days 1, 2) and ifosfamide 3 g/m2/day (days 1, 2, 3)
- Drug: gemcitabine 900 mg/m2 (days 1 and 8) and docetaxel 75 mg/m2 (day 8)
- Drug: trabectedin 1.3 mg/m2
- (and 3 more...)
|
Interventional
|
Phase 3 |
- Italian Sarcoma Group
- French Sarcoma Group
- Grupo Espanol de Investigacion en Sarcomas
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To compare the effect on disease-free survival of full-dose standard chemotherapy with histotype-tailored chemotherapy within the context of an integrated strategy for high risk soft tissue sarcomas typical of the adult.
- 1:overall survival 2:response in the whole population 3:response by RECIST and Choi in each different histotype 4:pathological response 5:feasibility of integration of preoperative chemotherapy with preoperative local-regional treatments 6:PET re
|
350 |
All |
18 Years and older (Adult, Older Adult) |
NCT01710176 |
ISG-STS 10-01 |
|
June 1, 2011 |
January 2019 |
January 2021 |
October 19, 2012 |
April 11, 2018 |
|
- Irccs Centro Di Riferimento Oncologico (Cro) -
Aviano (pn), Italy - Irccs Istituto Ortopedico Rizzoli (Ior) -
Bologna (BO), Italy - Pres.Ospedal.Spedali Civili Brescia -
Brescia (BS), Italy - (and 12 more...)
|
|
| 24 |
NCT03526679 |
Recruiting |
Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma |
- Leiomyosarcoma
- Liposarcoma
- Soft Tissue Sarcoma Adult
- Advanced Cancer
|
- Drug: Eribulin
- Drug: Lenvatinib
|
Interventional
|
Phase 1
Phase 2 |
- National Taiwan University Hospital
- Taipei Veterans General Hospital, Taiwan
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The objective response rate (ORR) based on RECIST 1.1
- 24-week progression-free survival (PFS) rate
- Overall survival (OS) rate at 12-months
- (and 2 more...)
|
30 |
All |
20 Years and older (Adult, Older Adult) |
NCT03526679 |
201801101MIPB |
LEADER |
July 2018 |
June 2021 |
June 2022 |
May 16, 2018 |
July 25, 2018 |
|
- National Taiwan University Hospital
Taipei, Taiwan - Taipei Veterans General Hospital
Taipei, Taiwan
|
|
| 25 |
NCT03104335 |
Recruiting |
Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial |
- Soft Tissue Sarcoma Adult
- Advanced Cancer
|
|
Interventional
|
Phase 2 |
- Peking University People's Hospital
- Peking University Shougang Hospital
- Peking University International Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR)
- Duration of Response (DR)
- Progression-Free Survival(PFS)
- Overall Survival(OS)
|
100 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT03104335 |
PekingUAH-sarcoma070330 |
|
April 1, 2017 |
June 30, 2019 |
November 30, 2019 |
April 7, 2017 |
January 17, 2018 |
|
- Peking University People's Hospital
Beijing, Beijing, China - Peking University Shougang Hospital
Beijing, Beijing, China - Peking University International Hospital
Beijing, Beijing, China
|
|
| 26 |
NCT02367924 |
Recruiting |
Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma |
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- 3 months progression free survival (PFS) rate
- 6 months progression free survival (PFS) rate
- Tumor control rate
- (and 6 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02367924 |
ET-D-023-13 |
YonSar |
July 16, 2015 |
July 2019 |
December 2020 |
February 20, 2015 |
November 16, 2018 |
|
- Dokusan GmbH und Co. KG; Praxisklinik Herne / Onkologie
Herne, Nordrhein-Westfalen, Germany - MVZ Marien-Hospital-Wesel GmbH
Wesel, Nordrhein-Westfalen, Germany - Onkologische Gemeinschaftspraxis Dr. med. Mohm & Dr. med. Prange-Krex
Dresden, Sachsen, Germany - (and 2 more...)
|
|
| 27 |
NCT03474094 |
Recruiting |
Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy |
|
- Combination Product: Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery
- Combination Product: 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy
- Combination Product: Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.
|
Interventional
|
Phase 2 |
- Centre Leon Berard
- Roche Pharma AG
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological impact of PD-L1 neutralisation (by atezolizumab) with or without radiotherapy versus radiotherapy alone in operable localised STS
- Rate of patients with complete or near-complete pathologic response
- Rate of patients with at least 50% of necrosis
- (and 12 more...)
|
69 |
All |
18 Years and older (Adult, Older Adult) |
NCT03474094 |
RT-Immune (ET16-132) |
RT-Immune |
August 1, 2018 |
July 31, 2020 |
July 31, 2021 |
March 22, 2018 |
September 28, 2018 |
|
- Centre Léon Bérard
Lyon, France - Institut Claudius Regaud
Toulouse, France - Institut Gustave Roussy
Villejuif, France
|
|
| 28 |
NCT03670069 |
Not yet recruiting |
Itacitinib in Treating Participants With Refractory Metastatic/Advanced Soft Tissue Sarcomas |
- Metastatic Leiomyosarcoma
- Metastatic Synovial Sarcoma
- Metastatic Undifferentiated Pleomorphic Sarcoma
- Round Cell Liposarcoma
|
- Drug: Itacitinib
- Other: Laboratory Biomarker Analysis
|
Interventional
|
Phase 1 |
- Fred Hutchinson Cancer Research Center
- Incyte Corporation
- National Cancer Institute (NCI)
|
Other / Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Difference in the percentage of cells which are immune inhibitory (CD11B+, CD163+) macrophages from pre-treatment to first post-treatment biopsy
- Progression-free survival (PFS)
- Incidence of adverse events
- (and 2 more...)
|
28 |
All |
18 Years and older (Adult, Older Adult) |
NCT03670069 |
RG1001680
NCI-2018-00615
9715
5P30CA015704 |
|
February 12, 2019 |
June 1, 2021 |
June 1, 2022 |
September 13, 2018 |
December 21, 2018 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
|
| 29 |
NCT02310243 |
Recruiting |
Study of Palbociclib in MLL-rearranged Acute Leukemias |
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
|
|
Interventional
|
Phase 1
Phase 2 |
- University of Ulm
- Pfizer
- Nationales Centrum für Tumorerkrankungen Heidelberg
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events
- Maximum tolerated dose of palbociclib
- overall response rate
- (and 4 more...)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02310243 |
AMLSG 23-14 |
|
July 2015 |
July 2018 |
July 2018 |
December 8, 2014 |
May 19, 2017 |
|
- Klinikum Augsburg
Augsburg, Germany - Helios Klinikum Bad Saarow
Bad Saarow, Germany - Charité Campus Benjamin Franklin
Berlin, Germany - (and 21 more...)
|
|
| 30 |
NCT03590210 |
Recruiting |
Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas |
- Metastatic Adult Soft Tissue Sarcoma
|
- Drug: Trabectedin
- Drug: Nivolumab
|
Interventional
|
Phase 2 |
- University Medicine Greifswald
- IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
- PharmaMar
- Bristol-Myers Squibb
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- progression free survival rate at 6 months - PFSR6
- safety, as measured by: - Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths - Incidence of clinical laboratory test abnormalities
- overall response rate (ORR)
- (and 4 more...)
|
74 |
All |
18 Years and older (Adult, Older Adult) |
NCT03590210 |
GISG-15 |
NiTraSarc |
June 8, 2018 |
December 2019 |
July 2021 |
July 18, 2018 |
July 20, 2018 |
|
- Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum Berlin-Brandenburg
Bad Saarow, Germany - Helios Klinikum Berlin Buch, Klinik für interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg
Berlin, Germany - Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie
Greifswald, Germany
|
|
| 31 |
NCT03719430 |
Not yet recruiting |
APX005M, Doxorubicin, Olaratumab in Advanced Sarcoma |
|
- Drug: Doxorubicin
- Drug: Olaratumab
- Drug: APX005M
|
Interventional
|
Phase 2 |
- Columbia University
- Apexigen, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate
- Recommended Dose Combination for APX005M, Doxorubicin and Olaratumab Combination Treatment
- Evaluation of Side Effects from APXO05M, Doxorubicin and Olaratumab Treatment
- Progression Free Survival
|
27 |
All |
18 Years and older (Adult, Older Adult) |
NCT03719430 |
AAAS0095 |
|
December 2018 |
December 2020 |
December 2023 |
October 25, 2018 |
October 25, 2018 |
|
- Columbia University Medical Center
New York, New York, United States
|
|
| 32 |
NCT03414229 |
Recruiting |
A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma |
|
- Drug: Epacadostat
- Drug: Pembrolizumab
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Incyte Corporation
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- number of patients with best objective response rate
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03414229 |
17-508 |
|
January 23, 2018 |
January 2021 |
January 2021 |
January 29, 2018 |
May 1, 2018 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
|
| 33 |
NCT03651375 |
Recruiting |
Hypofractionated Radiotherapy With Sequential Chemotherapy in Primary Unresectable or Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall |
- Sarcoma
- Fibrosarcoma
- Leiomyosarcoma
- (and 14 more...)
|
- Drug: Sequential chemotherapy - 3 courses of AI
- Radiation: Hypofractionated radiotherapy
|
Interventional
|
Phase 2 |
- Maria Sklodowska-Curie Institute - Oncology Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- R0 resection rate
- Conservative/limb-sparing resection rate
- Radiological response in diffusion-weighted MRI
- (and 4 more...)
|
50 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT03651375 |
URESARC1 |
UN-RESARC |
February 11, 2017 |
March 2019 |
March 2022 |
August 29, 2018 |
August 31, 2018 |
|
- Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, Poland
|
|
| 34 |
NCT01532687 |
Recruiting |
Gemcitabine Hydrochloride With or Without Pazopanib Hydrochloride in Treating Patients With Refractory Soft Tissue Sarcoma |
- Adult Alveolar Soft Part Sarcoma
- Adult Angiosarcoma
- Adult Desmoplastic Small Round Cell Tumor
- (and 16 more...)
|
- Drug: Gemcitabine Hydrochloride
- Other: Laboratory Biomarker Analysis
- Drug: Pazopanib Hydrochloride
- Other: Placebo
|
Interventional
|
Phase 2 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Best overall response rate
- Incidence of adverse events and serious adverse events, defined using the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0.
- (and 3 more...)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT01532687 |
7943
NCI-2012-00052
P30CA069533 |
|
March 2012 |
March 2019 |
March 2019 |
February 14, 2012 |
November 6, 2017 |
|
- OHSU Knight Cancer Institute
Portland, Oregon, United States
|
|
| 35 |
NCT03063632 |
Recruiting |
Pembrolizumab and Interferon Gamma-1b in Treating Patients With Stage IB-IVB Relapsed or Refractory Mycosis Fungoides and Sezary Syndrome |
- Metastatic Myxoid Liposarcoma
- Metastatic Round Cell Liposarcoma
- Metastatic Synovial Sarcoma
- (and 14 more...)
|
- Biological: Interferon Gamma-1b
- Other: Laboratory Biomarker Analysis
- Biological: Pembrolizumab
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) per global assessment of mycosis fungoides or sezary syndrome (confirmed and investigator assessed)
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Time to response
- (and 4 more...)
|
46 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT03063632 |
NCI-2017-00265
CITN-13
P30CA015704
U01CA154967 |
|
October 13, 2017 |
May 1, 2020 |
May 1, 2020 |
February 24, 2017 |
February 6, 2019 |
|
- Stanford Cancer Institute Palo Alto
Palo Alto, California, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Washington University School of Medicine
Saint Louis, Missouri, United States - (and 2 more...)
|
|
| 36 |
NCT03138161 |
Recruiting |
SAINT:Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma |
- Advanced Soft Tissue Sarcoma
- Metastatic Soft Tissue Sarcoma
|
- Drug: Trabectedin
- Drug: Ipilimumab
- Drug: Nivolumab
|
Interventional
|
Phase 1
Phase 2 |
- Sarcoma Oncology Research Center, LLC
- Bristol-Myers Squibb
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose
- Objective response rate (ORR), disease control rate (DCR)
- Progression free survival (PFS), 6 month PFS rate
- Overall survival (OS), 6 month OS rate
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT03138161 |
SOC-1702 |
|
April 13, 2017 |
June 30, 2020 |
August 31, 2020 |
May 3, 2017 |
September 6, 2018 |
|
- Sarcoma Oncology Research Center
Santa Monica, California, United States
|
|
| 37 |
NCT02584309 |
Recruiting |
Doxorubicin With Upfront Dexrazoxane Plus Olaratumab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma |
- Sarcoma, Soft Tissue
- Soft Tissue Sarcoma
- Undifferentiated Pleomorphic Sarcoma
- (and 8 more...)
|
- Drug: Dexrazoxane
- Drug: Doxorubicin
- Drug: Olaratumab
|
Interventional
|
Phase 2 |
- Washington University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS) (Arm 1 only)
- Cardiac-related mortality
- Incidence of heart failure or cardiomyopathy
- (and 2 more...)
|
73 |
All |
18 Years and older (Adult, Older Adult) |
NCT02584309 |
201510049 |
|
February 22, 2016 |
October 31, 2023 |
October 31, 2023 |
October 22, 2015 |
October 16, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 38 |
NCT03009201 |
Recruiting |
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery |
- Metastatic Angiosarcoma
- Metastatic Epithelioid Sarcoma
- Metastatic Fibrosarcoma
- (and 10 more...)
|
- Drug: Doxorubicin
- Drug: Ribociclib
|
Interventional
|
Phase 1 |
- OHSU Knight Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of DLTs of adverse events graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03
- Incidence of adverse events, SAEs, assessed by NCI CTCAE v 4.03
- Incidence of dose modifications (interruptions, reductions, intensity) due to adverse events
- (and 2 more...)
|
36 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT03009201 |
STUDY00016070
NCI-2016-01794
P30CA069533 |
|
January 2017 |
December 2018 |
December 2020 |
January 4, 2017 |
May 11, 2018 |
|
- OHSU Knight Cancer Institute
Portland, Oregon, United States
|
|
Create an RSS feed from your search for:
Download the search results for: