Combination Chemotherapy in Treating Patients With Sarcoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: intraoperative radiation therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pilot Study for Soft Tissue Sarcoma|
- Efficacy in terms of long-term disease-free survival [ Designated as safety issue: No ]
- Clinical response of the tumors [ Designated as safety issue: No ]
- Pathologic response of the tumors [ Designated as safety issue: No ]
- Long term disease-free survival [ Designated as safety issue: No ]
|Study Start Date:||October 1991|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- To evaluate the efficacy, in terms of clinical response, pathologic response, and long-term disease-free survival, of a multidrug chemotherapy regimen patients with spindle cell or small round cell sarcoma.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every 6 weeks for 2 courses.
- Local control: After completing induction therapy, patients are reevaluated for local control therapy. Some patients may undergo surgery and/or radiotherapy (e.g., brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or after surgery (weeks 15-16).
- Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18*. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 15. Patients are reevaluated for local control therapy at week 21.
NOTE: *Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18 or week 24.
- Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine, doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before. In week 39 patients receive etoposide and ifosfamide as before.
After completion of treatment, patients are followed periodically for at least 5 years.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Carola A. S. Arndt, MD||Mayo Clinic|