Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
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|ClinicalTrials.gov Identifier: NCT00017160|
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : June 27, 2013
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 or disease||Intervention/treatment||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 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017160
Show 235 Study Locations
|Study Chair:||Peter W. T. Pisters, MD||M.D. Anderson Cancer Center|