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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Washington University School of Medicine
St Louis, Missouri, United States
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.
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
Time frame: One year after protocol registration
Evaluate local recurrence rates
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.
Time frame: Until patient progressive disease or death
Evaluate disease-free survival rates
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.
Time frame: Until patient progressive disease or death
Evaluate regional recurrence rates
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.
Time frame: Until patient progressive disease or death
Evaluate distant recurrence rates
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.
Time frame: Until patient progressive disease or death
Evaluate overall survival rates
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.
Time frame: Until patient progressive disease or death
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