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 Title of Study: “Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma”
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
- 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.
- Drug: doxorubicin
- Drug: filgrastim
- Drug: ifosfamide
- Procedure: biological response modifier therapy
- Procedure: brachytherapy
- Procedure: chemotherapy
- Procedure: colony-stimulating factor therapy
- Procedure: conventional surgery
- Procedure: cytokine therapy
- Procedure: intraoperative radiotherapy
- Procedure: radiation therapy
- Procedure: surgery
Participating in This Clinical Trial
- 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
- Not specified
- Zubrod 0-2
- At least 2 years
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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
- Creatinine no greater than 1.6 mg/dL
- Two functional kidneys
- 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%
- 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:
- Not specified
- No prior doxorubicin or ifosfamide
- No prior chemotherapy for sarcoma
- Not specified
- No prior abdominal or pelvic irradiation
- See Disease Characteristics
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Radiation Therapy Oncology Group
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Peter W. T. Pisters, MD, Study Chair, M.D. Anderson Cancer Center
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.