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Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor (STRADA)

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ClinicalTrials.gov Identifier: NCT03023124
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

Brief Summary:
Phase II randomized study for the comparison of trabectedin versus doxorubicin plus dacarbazine in patients with advanced solitary fibrous tumor

Condition or disease Intervention/treatment Phase
Solitary Fibrous Tumors Drug: Trabectedin Drug: Adriamycin Drug: Dacarbazine Phase 2

Detailed Description:

Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or doxorubicin plus dacarbazine.

In case of progression or unacceptable toxicity while under the experimental treatment prior to the completion of the 6 cycles, the patients will be offered to cross to the other arm (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients
Actual Study Start Date : March 4, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trabectedin
trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles
Drug: Trabectedin
Treatment with trabectedin repeated every 21 days for 6 cycles

Experimental: Adriamycin and Dacarbazine
Adriamycin: 75 mg/m2/day, bolus, day 1 every 21 days for 6 cycles Dacarbazine: 400 mg/m2/day, days 1, 2 every 21 days for 6 cycles
Drug: Adriamycin
Treatment with Adriamycin at day 1 every 21 days for 6 cycles

Drug: Dacarbazine
Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles




Primary Outcome Measures :
  1. Overall Tumor Response Rate [ Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 54 weeks. ]
    evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1


Secondary Outcome Measures :
  1. Choi Response Rate [ Time Frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks ]
    Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.

  2. Overall Survival (OS) [ Time Frame: From enrollment up to 5 years ]
    Time from the date of enrollment to date of death

  3. Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks ]
    Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death

  4. Clinical Benefit Rate (CBR) [ Time Frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks ]
    Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months

  5. Response rate by RECIST after the cross over [ Time Frame: week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks ]
    Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over

  6. Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death [ Time Frame: From date of cross over until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks ]
    Survival free of progressive disease evaluated from

  7. Safety according to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: From enrollment every 3 weeks up to 54 weeks ]
    Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.
  2. Age ≥18 years
  3. Histological centrally and molecularly confirmed diagnosis of solitary fibrous tumor (inclusive of the last available tumor sample)
  4. Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
  5. Measurable or evaluable disease with RECIST
  6. Evidence of progression by RECIST during the 6 months before study entry
  7. Patients must be cytotoxic chemotherapy naïve (patients treated with neoadjuvant/adjuvant chemotherapy cannot be included) or could have received a previous target agent in front-line setting.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  9. Adequate bone marrow function
  10. Adequate organ function
  11. Cardiac ejection fraction ≥50% as measured by echocardiogram
  12. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
  13. No history of arterial and/or venous thromboembolic event within the previous 12 months.

Exclusion Criteria:

  1. Any prior treatment with cytotoxic chemotherapy
  2. >1 line of anticancer targeted agents
  3. Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing
  4. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
  5. Previous radiotherapy to 25 % of the bone marrow
  6. Major surgery within 4 weeks prior to study entry
  7. Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
  8. Pregnancy or breast feeding
  9. Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (24). Medical history of a myocardial infarction < 6 months prior to initiation of study treatment
  10. Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
  11. Known history of human immunodeficiency virus infection
  12. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
  13. Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI‐CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment
  14. Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
  15. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  16. Expected non-compliance to medical regimens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023124


Contacts
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Contact: Emanuela Marchesi +390516366 ext 470 emanuela.marchesi@ior.it

Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Not yet recruiting
Milano, MI, Italy, 20133
Contact: Silvia Stacchiotti, MD       silvia.stacchiotti@istitutotumori.mi.it   
Principal Investigator: Silvia Stacchiotti, MD         
Policlinico Universitario Campus Biomedico Not yet recruiting
Roma, RM, Italy, 00128
Contact: Bruno Vincenzi, MD    +3902225411123    b.vincenzi@unicampus.it   
Principal Investigator: Bruno Vincenzi, MD         
Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo - Recruiting
Candiolo, Italy, 10060
Ospedale Giaccone Not yet recruiting
Palermo, Italy
Contact: Giuseppe Badalamenti, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
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Principal Investigator: Silvia Stacchiotti, MD Italian Sarcoma Group

Publications:

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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT03023124     History of Changes
Other Study ID Numbers: ISG STRADA 2016
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Fibrous Tissue
Solitary Fibrous Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Trabectedin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents