Trial Information

A Pilot Study for Soft Tissue Sarcoma

OBJECTIVES:

- 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.