IMRT Tomotherapy for Esophagus Cancer

Study Overview
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Brief Summary
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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.

Official Title
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IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients

Conditions
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Esophagus Cancer

Intervention / Treatment
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* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT + Concurrent chemotherapy<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One year after protocol registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Until patient progressive disease or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMRT