Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall
Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma AJCC v7, Stage II Adult Soft Tissue Sarcoma AJCC v7
About this trial
This is an interventional treatment trial for Recurrent Adult Soft Tissue Sarcoma
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary soft tissue sarcoma T2a or T2b disease Superficial or deep tumor Grade 1, 2, 3, or 4 Tumor located on the upper extremity (including shoulder), lower extremity (including hip), or trunk Meets 1 of the following criteria: Tumor ? 8 cm in maximal diameter and grade 3 or 4 (intermediate or high grade) (cohort A) Tumor > 5 cm in maximal diameter and grade 1 or 2 (low grade) (cohort B) Locally recurrent disease allowed provided there has been no prior radiotherapy to the primary tumor No histologically confirmed rhabdomyosarcoma, extraosseous Ewing's primitive neuroectodermal tumors, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, angiosarcoma, desmoid tumors, or dermatofibrosarcoma protuberans No overt evidence of lung metastases (CT scan evidence of small incidental lesions without histologic diagnosis allowed) No evidence of other metastases No sarcoma of the head, neck, intra-abdominal, or retroperitoneal region Performance status - Zubrod 0-1 At least 2 years Absolute neutrophil count ? 1,500/mm^3 Platelet count ? 120,000/mm^3 Hemoglobin ? 8.0 g/dL (cohort A) No known hypercoagulable disorders, such as the following: APC resistance (factor V Leiden) Protein S deficiency Protein C deficiency Antithrombin III deficiency Hyperhomocystinemia Dysplasminogenemia High plasminogen activator inhibitor Dysfibrinogenemia Antiphospholipid syndrome Thrombocythemia Dysproteinemia Fibrin split products < 2 times upper limit of normal (ULN) Fibrinogen > 200 mg/dL Bilirubin ? 1.5 mg/dL (1.0 mg/dL for patients with Gilbert's syndrome) AST and ALT ? 2.0 times ULN PT and PTT < 1.25 times ULN (except in patients treated with anticoagulants for unrelated medical conditions [e.g., atrial fibrillation]) No history of hepatic cirrhosis Creatinine ? 1.5 mg/dL Creatinine clearance > 60 mL/min No atherosclerotic coronary artery disease that required bypass surgery within the past year No uncompensated coronary artery disease by ECG or physical examination No myocardial infarction within the past 6 months No severe or unstable angina within the past 6 months No uncompensated congestive heart failure No New York Heart Association class II-IV heart disease No symptomatic peripheral vascular disease No history of deep vein thrombosis Cohort A only: EF ? 50% within the past 6 months LVEF > 50% No pulmonary embolus except if caused directly by foreign body implants (e.g., central venous catheters or portacaths) No global neurocognitive symptomatology No fatigue ? grade 2 No history of uncontrolled seizures or uncontrolled seizure disorder No sensory neuropathy ? grade 2 except for localized neuropathy due to mechanical cause or trauma No other malignancies within the past 3 years except non-invasive malignancies (e.g., carcinoma in situ of the cervix, breast, or oral cavity) or squamous or basal cell skin cancer No history of uncontrolled myxedema No hypothyroidism ? grade 3 No active uncontrolled bacterial, viral, or fungal infection No other significant illness that would preclude surgery No other major illness or psychiatric impairment that would preclude study therapy No known AIDS Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective barrier methods of contraception for 4 weeks before, during, and for at least 4 weeks after study treatment No prior thalidomide No prior biologic therapy for this tumor No prior chemotherapy for this tumor See Disease Characteristics No prior radiotherapy for this tumor See Cardiovascular No other concurrent investigational drugs No concurrent sedating drugs No concurrent illegal sedating "recreational" drugs No concurrent alcohol intake of more than 1 drink per day
Sites / Locations
- Radiation Therapy Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A (chemotherapy, radiation, thalidomide, surgery)
Cohort B (thalidomide, radiation, surgery)
Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 26-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.