A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | December 2015 |
| End Date: | May 2019 |
| Contact: | Dawn Owen, M.D., Ph.D. |
| Email: | dawnowen@umich.edu |
| Phone: | 734-936-4300 |
This is a pilot single arm study with the primary endpoints of feasibility and preliminary
estimates of safety and efficacy. This protocol builds on over 25 years of experience with
high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the
global radiation dose based on a patient's measured sensitivity to treatment. This current
protocol uses functional imaging and specialized radiation planning techniques to spare
highly functional portions of the liver to preserve function. The investigators feel this
will further improve the safety and efficacy of RT for all patients by customizing treatments
to each. If this approach is promising, the investigators will proceed to a phase II
randomized study of standard versus spatially and dosimetrically adapted RT.
estimates of safety and efficacy. This protocol builds on over 25 years of experience with
high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the
global radiation dose based on a patient's measured sensitivity to treatment. This current
protocol uses functional imaging and specialized radiation planning techniques to spare
highly functional portions of the liver to preserve function. The investigators feel this
will further improve the safety and efficacy of RT for all patients by customizing treatments
to each. If this approach is promising, the investigators will proceed to a phase II
randomized study of standard versus spatially and dosimetrically adapted RT.
Inclusion Criteria:
- Patients must have hepatocellular carcinoma.
- Patients must not have extrahepatic cancer.
- Patients must not be eligible for a curative liver resection or have refused resection
- Patients must have recovered from the acute effects of prior liver-directed therapy
and 4 weeks must have passed since the last procedure and protocol therapy.
- Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod
performance status is a measure that attempts to quantify a cancer patients' general
well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes
death).
- Patients must be 18 years of age or older.
- Patients must have adequate organ function.
- Patients must understand and be willing to sign an IRB (Institutional Review Board)
approved informed consent form.
Exclusion Criteria:
- Patients with known allergies to intravenous iodinated contrast agents.
- Patients with a contraindication to contrast-enhanced MRI are excluded.
We found this trial at
1
site
Ann Arbor, Michigan 48187
Principal Investigator: Dawn Owen, M.D., Ph.D.
Phone: 734-936-4300
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