Esophagus Cancer
Conditions
Keywords
IMRT
Brief summary
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.
Interventions
RADIATIONIMRT
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 * Karnofsky Performance Status of \>= 60 * TNM Stages T1-4, N0-3, M0 * Pathologic confirmation of esophagus cancer * Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy * Evaluation by surgeon determines that patient is unresectable
Exclusion criteria
* Age \< 18 * Karnofsky Performance Status \< 60 * Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual) * Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy. * Pregnant or lactating, if female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer. | One year after protocol registration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate local recurrence rates | Until patient progressive disease or death | 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 survival rates | Until patient progressive disease or death | 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 regional recurrence rates | Until patient progressive disease or death | 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 distant recurrence rates | Until patient progressive disease or death | 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 overall survival rates | Until patient progressive disease or death | 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. |
Countries
United States
Outcome results
None listed