Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma


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.

Full Title of Study: “Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment

Detailed Description


- Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide, radiotherapy, and surgical resection.

- Assess local-regional control in patients treated with this regimen.

- Determine the disease-free survival of patients treated with this regimen.

- Determine the pathologic response in patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

- Determine the complications in patients treated with this regimen.

OUTLINE: Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4. Patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity. Beginning 2-4 weeks after chemotherapy, patients undergo radiotherapy daily, 5 days a week, for 5-6 weeks. Beginning 4-7 weeks after radiotherapy, patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 24 months.


  • Drug: doxorubicin
  • Drug: filgrastim
  • Drug: ifosfamide
  • Procedure: biological response modifier therapy
  • Procedure: brachytherapy
  • Procedure: chemotherapy
  • Procedure: colony-stimulating factor therapy
  • Procedure: conventional surgery
  • Procedure: cytokine therapy
  • Procedure: intraoperative radiotherapy
  • Procedure: radiation therapy
  • Procedure: surgery

Participating in This Clinical Trial


  • 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



  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 2 years


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.6 mg/dL
  • Two functional kidneys


  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease
  • Ejection fraction at least 50%


  • No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No serious medical or psychiatric illness that would preclude study entry
  • No obvious bowel obstruction
  • No hypersensitivity to E. coli-derived products
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Oral caloric intake at least 1,500 kCal/day


Biologic therapy:

  • Not specified


  • No prior doxorubicin or ifosfamide
  • No prior chemotherapy for sarcoma

Endocrine therapy:

  • Not specified


  • No prior abdominal or pelvic irradiation


  • See Disease Characteristics

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radiation Therapy Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter W. T. Pisters, MD, Study Chair, M.D. Anderson Cancer Center

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