Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

Basic Trial Information

Objectives

I.  Evaluate the efficacy of primary chemotherapy, wide surgical resection, 
adjuvant chemotherapy, and radiotherapy on local control, metastasis-free 
survival, and overall survival in patients with poor-prognosis soft tissue 
sarcoma of the extremity and trunk.

II.  Evaluate tumor response to primary chemotherapy as an indicator of local 
and systemic disease control in poor-prognosis soft tissue sarcoma.

III.  Evaluate the toxicity of this regimen in this patient population.

IV.  Correlate biological parameters to treatment outcomes in conjunction with 
companion protocol SWOG-9136 (Biologic Parameters Protocol).

Entry Criteria

Disease Characteristics:

Histologically documented primary or locally recurrent soft tissue sarcoma of
the extremity or trunk area
  Histologic confirmation by open incisional biopsy or (if previously done)
  core needle biopsy required
     No excisional biopsy

  Poor-prognosis disease required, i.e.:
     Grade G3 lesion and at least 5 cm (AJCC stage IIIB)
     Grade G2 lesion and at least 5 cm (AJCC stage IIB) and deep to the
        superficial fascia

  Eligible truncal lesions include sarcoma of the head and neck,
  retroperitoneum, and mediastinum/chest cavity

The following are not eligible:
  Soft tissue Ewing's sarcoma
  Kaposi's sarcoma
  Mesothelioma
  Sarcomas of bone
  Regional lymph node involvement
  Sarcomas originating in organs or in the retroperitoneal or pelvic cavities

No metastases on physical exam and chest CT and, in retroperitoneal sarcomas,
CT of chest and abdomen

Concurrent registration on protocol SWOG-9136 (Biologic Parameters Protocol)
required

Prior/Concurrent Therapy:

Biologic therapy:
  No prior biologic therapy for soft tissue sarcoma
  No plans for concurrent biologic therapy

Chemotherapy:
  No prior systemic chemotherapy for soft tissue sarcoma
  No plans for concurrent chemotherapy

Endocrine therapy:
  No plans for concurrent hormonal therapy

Radiotherapy:
  Prior local radiotherapy allowed
  No plans for concurrent radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  Not specified

Performance status:
  SWOG 0-2

Hematopoietic:
  ANC at least 1,500
  Platelets normal
  Hemoglobin greater than 8 g/dL

Hepatic:
  Bilirubin normal

Renal:
  Creatinine normal

Cardiovascular:
  Left ventricular ejection fraction at least 50% by MUGA or normal by
     echocardiogram
  No myocardial infarction within 6 months
  No active unstable angina pectoris
  No uncontrolled ventricular arrhythmia

Other:
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Adequately treated in situ cervical cancer
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

99 patients will be accrued at an estimated rate of 33 patients/year.

Outline

Patients with progressive disease proceed to Regimen B after surgery unless 
prior radiation doses prohibit further irradiation.

Regimen A:  3-Drug Combination Chemotherapy with Urothelial Protection 
followed by Surgery, with (as feasible) Intraoperative Radiotherapy, followed 
(as indicated) by 3-Drug Combination Chemotherapy with Urothelial Protection.  
Doxorubicin, DOX, NSC-123127; Dacarbazine, DTIC, NSC-45388; Ifosfamide, IFF, 
NSC-109724; with Mesna, NSC-113891; followed by wide surgical excision; with 
(as feasible) intraoperative tumor site irradiation using isotopic implant or 
electrons; followed (as indicated) by DOX; DTIC; IFF; with Mesna.

Regimen B:  Radiotherapy.  Tumor irradiation using equipment producing at 
least 1 MeV energies (x-rays or electrons allowed).

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Mark Zalupski, MD, Protocol chair(Contact information may not be current)		Ph: 313-745-4700; 800-527-6266

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