Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT01215500|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2010
Last Update Posted : July 6, 2017
Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.
The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Tumor Cancer Melanoma Sarcoma Carcinoma||Radiation: Hypofractionated RT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer|
|Study Start Date :||January 2005|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
|Experimental: Radiation therapy||
Radiation: Hypofractionated RT
RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy:
For all sites the dose levels are as follows:
- Dose-limiting toxicities [ Time Frame: 30-90 days ]The dose limiting toxicities occurring within the initial observation period will be defined.
- maximum tolerated dose of hypofractionated RT [ Time Frame: 30-90 days ]
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): NCT01215500
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Steven Chmura, MD||University of Chicago|