Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004123|
Recruitment Status : Completed
First Posted : March 23, 2004
Last Update Posted : July 30, 2012
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Doxorubicin hydrochloride (DOX) Procedure: Conventional surgery Radiation: Intraoperative radiation therapy (IORT) Radiation: Radiation Therapy (RT)||Phase 1|
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of preoperative external beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy in patients with resectable primary or recurrent soft tissue sarcoma of the retroperitoneum. II. Assess radiologic and pathologic response in patients treated with this preoperative regimen.
OUTLINE: This is a dose-escalation study of external beam radiotherapy. Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks. Patients with stable or responding disease undergo surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after completion of chemoradiotherapy. Patients receive intraoperative radiotherapy (IORT) to the tumor bed if all gross disease has been resected and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within a single IORT field (maximum 15 cm). Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Preoperative Chemoradiation and Intraoperative Radiation Therapy in the Treatment of Retroperitoneal Sarcoma|
|Study Start Date :||July 1997|
|Actual Primary Completion Date :||July 2001|
|Actual Study Completion Date :||October 2009|
Experimental: RT + DOX + IORT
Preoperative external beam radiotherapy (RT) combined with doxorubicin (DOX) and followed by intraoperative radiotherapy (IORT); dose-escalation study of external beam radiotherapy.
Drug: Doxorubicin hydrochloride (DOX)
Doxorubicin IV bolus followed immediately by IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks.
Other Names:Procedure: Conventional surgery
Surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after chemoradiotherapyRadiation: Intraoperative radiation therapy (IORT)
Intraoperative radiotherapy (IORT) to tumor bed if all gross disease has been resected and if area of maximal tumor adherence to retroperitoneum can be encompassed within a single IORT field (maximum 15 cm).Radiation: Radiation Therapy (RT)
5 days a week for 4 weeks
- Maximum Tolerated Dose (MTD) of Preoperative External Beam Radiotherapy, Doxorubicin + Intraoperative Radiotherapy [ Time Frame: 6 weeks ]The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity
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): NCT00004123
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Peter W. Pisters, MD||M.D. Anderson Cancer Center|