Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer|
- Dose-limiting toxicities [ Time Frame: 30-90 days ] [ Designated as safety issue: Yes ]The dose limiting toxicities occurring within the initial observation period will be defined.
- maximum tolerated dose of hypofractionated RT [ Time Frame: 30-90 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Radiation: Hypofractionated RT
- 8 Gy/ fraction x 3 fractions = 24 Gy
- 10 Gy/fraction x 3 fractions = 30 Gy
- 12 Gy/fraction x 3 fractions = 36 Gy
- 14 Gy/fraction x 3 fractions = 42 Gy
- 16 Gy/fraction x 3 fractions = 48 Gy
- 18 Gy/fraction x 3 fractions = 52 Gy
- 20 Gy/fraction x 3 fractions = 60 Gy
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: