Overview
Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma
Status:
Completed
Completed
Trial end date:
2009-10-01
2009-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
M.D. Anderson Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Doxorubicin
Liposomal doxorubicin
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven resectable primary orrecurrent soft tissue sarcoma of the retroperitoneum Greatest dimension of the
3-dimensional assessment of tumor size must be 5-35 cm Grade 2 or 3, including
dedifferentiated liposarcoma and retroperitoneal recurrences of gastrointestinal
leiomyosarcoma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Zubrod 0 or
1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than
2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Renal function
normal Creatinine less than 1.6 mg/dL Gastrointestinal: Must maintain adequate oral
nutrition (90-100% of estimated need for calories and protein) and be free of nausea and
vomiting prior to radiotherapy (feeding tube allowed) Other: Prior malignancy allowed at
the discretion of the protocol investigator No other serious uncontrolled medical condition
Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy Surgery: See
Disease Characteristics