Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Completed 10 to 65 NCI NCI-80-C-45 NCI-SB-S9, NCI-T83-1103N, T83-1103

Objectives

I.  Evaluate the efficacy of intraoperative electron radiotherapy combined 
with low-dose postoperative external beam radiotherapy vs. postoperative 
conventional external beam radiotherapy for the local control of soft tissue 
sarcoma.
II.  Evaluate toxicity and patient tolerance of both intraoperative 
radiotherapy with low-dose external beam postoperative radiation and 
postoperative conventional external beam radiotherapy.
III.  Evaluate the efficacy in prolonging disease-free interval in 
retroperitoneal sarcoma by adjunctive chemotherapy with 
adriamycin/cyclophosphamide/methotrexate.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with biopsy-proven soft 
tissue sarcomas of one of the following types:  liposarcoma, rhabdomyosarcoma, 
synoviosarcoma, unclassifiable sarcoma, fibrosarcoma, neurofibrosarcoma, 
leiomyosarcoma, malignant mesenchymoma, angiosarcoma, malignant fibrous 
histiocytoma.  There must be no clinical evidence of regional or distant 
metastases.  Patients may present with local recurrence following local 
excision if all other requirements are met.  There may be no prior 
chemotherapy or radiotherapy for the sarcoma.  Bone marrow function must be 
adequate, and patients must be between the ages of 10 and 65 years, with 21 
years the lower age limit for rhabdomyosarcoma patients.

Expected Enrollment

26 patients will be required for each radiotherapy arm, accrual estimated to 
take 5 years.  36 patients will be required in each chemotherapy arm.

Outline

Randomized study.  Randomize patients to Arms I and II.  Randomize patients 
from Arm I to Arms III and IV and those from Arm II to Arms IV and V.
Arm I:  Surgery plus Conventional Postoperative External Beam Photon 
Radiotherapy.
Arm II:  Surgery plus Intraoperative 6-11 MeV Electron Radiotherapy with 
Radiosensitization plus Postoperative Low-Dose External Beam Radiotherapy.  
Misonidazole, MNI, NSC-261037.
Arm III:  3-Drug Combination Chemotherapy plus Leucovorin Rescue.  Adriamycin, 
ADR, NSC-123127; Cyclophosphamide, CTX, NSC-26271; Methotrexate, MTX, NSC-740; 
Citrovorum Factor, CF, NSC-3590.
Arm IV:  No further treatment.
Arm V:  3-Drug Combination Chemotherapy plus Leucovorin Rescue.  ADR; CTX; 
MTX-CF.

Sindelar WF, Kinsella TJ, Chen PW, et al.: Intraoperative radiotherapy in retroperitoneal sarcomas. Final results of a prospective, randomized, clinical trial. Arch Surg 128 (4): 402-10, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

William F. Sindelar, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 301-496-4345