Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal 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: NCT01034566|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2009
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adult Soft Tissue Sarcoma||Radiation: Proton Beam Radiation Therapy||Phase 1|
Detailed DescriptionPRIMARY OBJECTIVES:
I. To determine the feasibility and toxicity of proton radiotherapy for retroperitoneal sarcomas.
II. To determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas.
III. To determine the maximally tolerated dose of proton radiotherapy for patients with potentially resectable retroperitoneal sarcoma. (Pre-operative cohort) IV. To assess acute side effects from irradiation using proton beam therapy and dose/volume constraints that are derived from conventional radiotherapy. (Postoperative cohort)
I. To assess the clinical effectiveness of proton radiotherapy for retroperitoneal sarcoma.
II. To determine the long-term toxicity of proton radiotherapy to the abdomen and pelvis region.
III. To monitor for effects of proton treatment on tumor and normal tissues using radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (preoperative cohort only).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Masking:||None (Open Label)|
|Official Title:||Proton Radiotherapy for Retroperitoneal Sarcoma|
|Study Start Date :||November 2009|
|Primary Completion Date :||November 2012|
Experimental: Arm I
Patients undergo proton beam radiotherapy 5 days a week for 6 (preoperative patients) or 8 (post-operative patients) weeks in the absence of disease progression or unacceptable toxicity.
|Radiation: Proton Beam Radiation Therapy|
- Acute toxicity as assessed by NCI CTC Version 3.0 [ Time Frame: Within 60 days of completion of radiotherapy ]
- Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system [ Time Frame: After 60 days of therapy ]
- Clinical efficacy (local recurrence-free survival, distant metastasis-free survival, and overall survival
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): NCT01034566
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Curtiland Deville, MD||Abramson Cancer Center of the University of Pennsylvania|