IMRT Tomotherapy for Esophagus Cancer
Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients|
- The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer. [ Time Frame: One year after protocol registration ] [ Designated as safety issue: Yes ]
The study will be deemed infeasible if one or more of the following results occur:
15% of patients experience any grade 4 acute toxicity judged to be related to his/her external radiation treatment
- within 1 year of protocol registration, >15% of patients develop any grade 4 late toxicity judged to be related to his/her external radiation treatment
- within 1 year of protocol registration, any patient dies from causes judged to be related to his/her external beam radiation treatment
- Evaluate local, regional and distant recurrence rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.
- Evaluate disease-free and overall survival rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: IMRT + Concurrent chemotherapy
180 cGy daily fractions to a total dose of 5400 cGy to PTV1 and 200 cGy daily fractions to a total dose of 6000 cGy to PTV2. Once a day, five days a week, for approximately 6 weeks.
Planned chemotherapy: cisplatin (75 mg/m2) day 1 and 5-FU (1000 mg/m2) days 1-4 on weeks 1, 5, 10, and 14 of therapy. Please note that drug regimens and doses may vary and will be at the discretion of the medical oncologist.
|Radiation: IMRT Drug: Concurrent chemotherapy|
|Contact: Jeffrey Bradley, MD||(314) firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator: Jeffrey Bradley, MD|
|Sub-Investigator: Murty Goddu, Ph.D.|
|Sub-Investigator: Sasa Mutic, M.S.|
|Sub-Investigator: A Craig Lockhart, M.D.|
|Sub-Investigator: Feng Gao, M.D., Ph.D.|
|Principal Investigator:||Jeffrey Bradley, MD||Washington University School of Medicine|