A Phase III Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients with Metastatic Cancer

Protocol
10-154
Full Title
A Phase III Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients with Metastatic Cancer
Phase
III
Purpose

The purpose of this study is to find out which way of giving high-dose radiation therapy works best for the treatment of cancer that has spread. This study will look at the safety and effectiveness of giving 27 Gy of radiation in three fractions of 9 Gy each (over five days) or 24 Gy in one fraction (in one day) using image-guided intensity-modulated radiotherapy (IG-IMRT).

IG-IMRT is radiation that is given directly to the cancer site, and reduces the exposure to nearby normal tissue. Currently there are no studies that compare the side effects and effectiveness of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session) in patients with metastatic cancer.

Patients in this study will be randomly assigned to receive either 27 Gy over five days or 24 Gy in one day.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have cancer that has spread to the bone, spine, soft tissue, or lymph nodes.
  • The patient’s cancer must be limited to five sites or less.
  • Patients may not have had prior radiation to the area targeted for treatment in this study.
  • Patients may not have had chemotherapy within 2 weeks of receiving the radiation in this study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Zelefsky at 212-639-6802.

Locations