Radiation Therapy, Sorafenib, and Surgery in Treating Patients With Soft Tissue Sarcoma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy given together with sorafenib followed by surgery in treating patients with soft tissue sarcoma.
Drug: sorafenib tosylate
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall|
- Maximal-tolerated dose of sorafenib tosylate when combined with conformal radiotherapy (Phase I) [ Time Frame: Dec 2012 ] [ Designated as safety issue: Yes ]
- Pathological tumor response by RECIST criteria (Phase II) [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
- Toxicities [ Time Frame: Dec 2012 ] [ Designated as safety issue: Yes ]
- Radiographic response rate by RECIST criteria [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
- Time to local recurrence, local disease-free survival (DFS), distant DFS, overall DFS, progression-free survival, and overall survival [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
- Transfer constant and the initial area under the gadolinium concentration time curve (phase II) [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
single treatment arm
|Drug: sorafenib tosylate Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: 3-dimensional conformal radiation therapy|
- To determine the maximum tolerated dose of sorafenib tosylate when combined with conformal external beam radiotherapy prior to resection with curative intent in patients with soft tissue sarcoma of the extremity or body wall. (Phase I)
- To determine the rate of near-complete (≥ 95% tumor necrosis) pathological response to this regimen in these patients. (Phase II)
- To describe the toxicities associated with this regimen.
- To determine the rate of R0 (negative resection margin), R1 (microscopically positive resection margin), and R2 (macroscopically positive resection margin) following this regimen.
- To determine the radiographic response rate to this regimen as defined by conventional RECIST criteria.
- To obtain preliminary data regarding local disease control, distant disease control, progression-free survival, and overall survival with this regimen.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
Patients receive oral sorafenib tosylate twice daily on days 1-35 and undergo conformal radiotherapy 5 days a week for 5 weeks.
Patients undergo dynamic contrast-enhanced MRI scanning at baseline and day 63 followed by surgical resection on day 70.
After completion of study therapy, patients are followed every 4 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805727
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Robert Canter, MD||University of California, Davis|