Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Rec… (NCT00017160) | Clinical Trial Compass
WithdrawnPhase 2
Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
United States0
Plain-language 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.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 He…