Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients who have primary or recurrent sarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Ifosfamide; Immunologic Factors; Isophosphamide mustard; Liposomal doxorubicin; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary or recurrent soft tissue sarcoma of the retroperitoneum or pelvis

• No rhabdomyosarcoma, extraosseous Ewing's sarcoma, primitive neuroectodermal tumor, osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or aggressive fibromatosis

• No sarcoma that does not allow sparing of two-thirds of 1 kidney within planned irradiation field

• Radiographically measurable disease greater than 5 cm (T2) by CT scan or MRI of the abdomen and pelvis

• High-grade (grade 3/3, 3/4, 4/4) disease greater than 5 cm OR

• Moderate-grade (grade 2/3, 2/4) recurrent disease greater than 10 cm

• Eligible for gross total resection (R0 or R1)

• No prior subtotal (R2) resection

• Partial debulking OR subtotal tumor resection with residual gross disease

• Fewer than 4 equivocal pulmonary lesions each less than 3 mm in diameter by CT scan

• No multifocal disease suggestive of regional nodal involvement

• No metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 2 years

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• AST no greater than 3 times upper limit of normal

• Albumin at least 3.5 g/dL

Renal:

• Creatinine no greater than 1.6 mg/dL

• Two functional kidneys

Cardiovascular:

• No congestive heart failure

• No myocardial infarction within the past 6 months

• No New York Heart Association class III or IV heart disease

• Ejection fraction at least 50%

Other:

• No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

• No serious medical or psychiatric illness that would preclude study entry

• No obvious bowel obstruction

• No hypersensitivity to E. coli-derived products

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Oral caloric intake at least 1,500 kCal/day

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior doxorubicin or ifosfamide

• No prior chemotherapy for sarcoma

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior abdominal or pelvic irradiation

Surgery:

• See Disease Characteristics