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.
|Stage III Adult Soft Tissue Sarcoma Recurrent Adult Soft Tissue Sarcoma Stage IVA Adult Soft Tissue Sarcoma Stage IIB Adult Soft Tissue Sarcoma Stage IIC Adult Soft Tissue Sarcoma||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||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017160
Show 235 Study Locations
|Study Chair:||Peter W. T. Pisters, MD||M.D. Anderson Cancer Center|