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

Radiation Therapy Oncology Group

Status and phase: Withdrawn; Phase 2

Conditions: Stage IIC Adult Soft Tissue Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IVA Adult Soft Tissue Sarcoma; Stage IIB Adult Soft Tissue Sarcoma

Treatments: Drug: doxorubicin; Procedure: colony-stimulating factor therapy; Procedure: conventional surgery; Procedure: cytokine therapy; Procedure: surgery; Drug: filgrastim; Procedure: brachytherapy; Procedure: chemotherapy; Procedure: intraoperative radiotherapy; Drug: ifosfamide; Procedure: biological response modifier therapy; Procedure: radiation therapy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00017160

CDR0000068657

RTOG-S-0124

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide, radiotherapy, and surgical resection.
• Assess local-regional control in patients treated with this regimen.
• Determine the disease-free survival of patients treated with this regimen.
• Determine the pathologic response in patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.
• Determine the complications in patients treated with this regimen.

OUTLINE: Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4. Patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity. Beginning 2-4 weeks after chemotherapy, patients undergo radiotherapy daily, 5 days a week, for 5-6 weeks. Beginning 4-7 weeks after radiotherapy, patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 24 months.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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