Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma (NeoWTS)
This study has been completed.
Sponsor:
University of Heidelberg
Collaborator:
German Cancer Research Center
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01382030
First received: June 17, 2011
Last updated: June 23, 2011
Last verified: June 2011
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Purpose
Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma |
Drug: EIA chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma |
Resource links provided by NLM:
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- Disease-free survival [ Time Frame: 2 years after study completion ] [ Designated as safety issue: No ]Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: 2 years after study completion ] [ Designated as safety issue: No ]Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.
- Grade of histological necrosis [ Time Frame: After definite surgery, approx. 12-15 weeks after study inclusion ] [ Designated as safety issue: No ]Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.
- Hematological toxicity [ Time Frame: Once weekly for an average of 8 months ] [ Designated as safety issue: Yes ]Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.
- Renal Toxicity [ Time Frame: Once weekly for an average of 8 months ] [ Designated as safety issue: Yes ]Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.
- Liver Toxicity [ Time Frame: Once weekly for an average of 8 months ] [ Designated as safety issue: Yes ]Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.
- Correlation of Tumor Necrosis and Decline in PET SUV [ Time Frame: After tumor resection, approx. 12-15 weeks after study inclusion ] [ Designated as safety issue: No ]Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.
- Cardiac Toxicity [ Time Frame: Every 6 weeks for an average of 8 months ] [ Designated as safety issue: Yes ]Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.
- Radiologic Tumor Response [ Time Frame: Every 6 weeks for an average of 8 months, then every 3 months for 2 years ] [ Designated as safety issue: No ]Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.
| Enrollment: | 50 |
| Study Start Date: | June 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm
All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.
|
Drug: EIA chemotherapy
ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1
|
Detailed Description:
The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Soft tissue sarcoma histology
- Tumor size >= 5 cm
- Deep/extracompartimental localization
- Grade 2/3 (FNCLCC)
- Patients with inadequate previous therapy
- Age 18-65 years
- normal bone marrow function
- normal liver function
- normal renal function
- Karnofsky index >=80%
Exclusion Criteria:
- Chordoma
- Chondrosarcoma
- Kaposi´ sarcoma
- Neuroblastoma
- Mesothelioma
- Osteosarcoma/Ewings´sarcoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382030
Locations
| Germany | |
| Heidelberg University Clinics | |
| Heidelberg, Baden-Wuerttemberg, Germany, 69120 | |
Sponsors and Collaborators
University of Heidelberg
German Cancer Research Center
Investigators
| Principal Investigator: | Gerlinde Egerer, MD | Department of Hematology, Heidelberg University Clinics |
More Information
No publications provided by University of Heidelberg
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | PD Dr. med. Gerlinde Egerer, Department of Hematology, Heidelberg University Clinics |
| ClinicalTrials.gov Identifier: | NCT01382030 History of Changes |
| Other Study ID Numbers: | 2004-002501-72, 2004-002501-72 |
| Study First Received: | June 17, 2011 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Heidelberg:
|
Soft tissue sarcoma High-risk Neoadjuvant |
Adjuvant Chemotherapy Radiotherapy |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013