Stereotactic Radiotherapy (SRT) Liver
Recruitment status was Recruiting
A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Their median survival time is 3 to 12 months. Stereotactic radiation (SRT) (highly conformal radiotherapy (CRT)) is a treatment option for these patients with unresectable liver cancer, now possible due to improvements in our ability to localize and immobilize liver tumors and an improved understanding of the partial liver volume tolerance to radiation. SRT should permit liver tumors to be treated to tumorcidal doses while sparing the uninvolved liver, decreasing the risk of treatment related normal tissue toxicity. With such conformal radiation, it is possible to deliver radiation in fewer fractions than traditionally required, which should be more convenient for patients. In this study, CRT will be delivered during shallow breathing or breath hold to minimize organ motion due to breathing, decreasing the volume of normal liver that must be irradiated.
Procedure: Stereotactic radiotherapy (SRT) or highly conformal (CRT)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Highly Conformal Radiotherapy for Unresectable Liver Metastases and Hepatobiliary Carcinoma|
- Phase I: To evaluate feasibility and maximally tolerated dose of SRT
- Phase II: To determine with more confidence the rate and spectrum of all toxicities that occur at the maximally tolerated dose of radiation.
- To evaluate local control, progression-free survival and survival of patients with unresectable primary hepatobiliary cancer and metastatic liver cancer treated with SRT.
- To evaluate the quality of life.
- To evaluate changes in liver function following SRT.
- To evaluate patterns of breathing at and during RT.
- To develop more confidence in a revised normal tissue complication probability (NTCP) model for radiation induced liver toxicity and collect preliminary data to determine how the liver responds to radiation.
- To determine whether serum cytokines and P-III-P can help predict RILD.
|Study Start Date:||July 2003|
|Contact: Laura Dawson, MDfirstname.lastname@example.org|
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Laura Dawson, MD 416-946-2125 email@example.com|
|Principal Investigator: Laura Dawson, MD|
|Principal Investigator:||Laura Dawson, MD||Princess Margaret Hospital, Canada|