Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Condition: Endometrial Cancer; Kidney Cancer; Ovarian Cancer; Pheochromocytoma; Sarcoma
MeSH terms: Sarcoma; Endometrial Neoplasms; Kidney Neoplasms; Pheochromocytoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known whether giving chemotherapy after surgery is
      more effective than surgery alone in treating soft tissue sarcoma.

      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without
      chemotherapy in treating patients who have soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the local disease control, overall survival, and relapse-free survival in
           patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin
           and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after
           definitive surgery.

        -  Compare the toxicity and morbidity of these regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head,
      or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of
      primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative
      radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).

      Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.

      No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery.
      Patients with complete resection undergo radiotherapy assessment and then randomization.
      Patients with incomplete or marginal resection (except for central lesions) undergo
      re-excision and, in the absence of macroscopic disease, assessment for postoperative
      radiotherapy followed by randomization.

        -  Randomization: Patients are randomized to 1 of 2 treatment arms.

             -  Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning
                within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined
                below.

             -  Arm II: Beginning within 4 weeks after surgery, patients receive high-dose
                doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF
                subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and
                continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning
                within 6 weeks after completion of chemotherapy, eligible patients undergo
                radiotherapy as outlined below.

        -  Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days
           a week for 6-6.6 weeks. Patients with complete microscopic resection undergo
           radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for
           1 week.

      Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months
      for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.
    

Intervention name(s): filgrastim; doxorubicin hydrochloride; ifosfamide; isolated perfusion; adjuvant therapy; conventional surgery; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide
Allocation: Randomized
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult alveolar soft-part sarcoma; adult epithelioid sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult malignant mesenchymoma; adult rhabdomyosarcoma; localized benign pheochromocytoma; regional pheochromocytoma; recurrent pheochromocytoma; stage II uterine sarcoma; stage III uterine sarcoma; recurrent uterine sarcoma; uterine carcinosarcoma; uterine leiomyosarcoma; endometrial stromal sarcoma; ovarian sarcoma; clear cell sarcoma of the kidney; stage II adult soft tissue sarcoma