A Phase 2 interventional study of doxorubicin and filgrastim in Stage III Adult Soft Tissue Sarcoma, Recurrent Adult Soft Tissue Sarcoma and Stage IVA Adult Soft Tissue Sarcoma, sponsored by Radiation Therapy Oncology Group. Withdrawn at 235 sites in 2 countries. Per ClinicalTrials.gov, last updated 2013-06-27.
Sponsored by Radiation Therapy Oncology Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
Browse Sarcoma studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Showing the first 100 of 235 sites across 2 countries.
This study is withdrawn, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Radiation Therapy Oncology Group