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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017160 |
Purpose
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.
| Condition | Intervention | Phase |
|
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 II |
| MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Ifosfamide Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal 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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations![]() |
Show 235 Study Locations |
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Peter W. T. Pisters, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000068657, RTOG-S-0124 |
| First Received: | June 6, 2001 |
| Last Updated: | January 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00017160 |
| Health Authority: | United States: Federal Government |
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