Organ Motion and Early Tumor Response Measurement

Study Overview
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Brief Summary
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To quantify motion based variation of the target volume of the primary tumor over the course of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate appropriate PTV (planning target volume) margins according to the margins recipe for patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation in order to personalize radiation treatment, resulting in either better target coverage or a reduction in normal tissue radiation exposure.

Detailed Description
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A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans. Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response. Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.

Official Title
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Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer

Conditions
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Esophageal Cancer, Chemoradiation

Intervention / Treatment
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* Other: Fiducial markers
* Other: Fiducial markers, Pet and MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy T3N0M0 or T1-4N1-3M0. Patients with M1 disease solely on the basis of supraclavicular metastasis and not a junction tumor as primary are eligible. (AJCC 7th edition,). WHO performance status ≤2 (WHO scale) Clinically operable for R0 resection in the opinion of an experienced upper gastrointestinal or thoracic surgeon for patients planned for trimodality Tumor localization at least 2cm from the upper esophageal sphincter and invading no more than 5cm into gastric cardia Age ≥ 18 years Written informed consent before endoscopy or EUS Exclusion criteria: Prior treatment with thoracic surgery or thoracic radiotherapy Pregnancy Severe cardiopulmonary restriction

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neoadjuvant or definitive chemoradiation<br>Esophageal cancer patients planned for neoadjuvant or definitive chemoradiation. | Other: Fiducial markers<br> <br> Other: Fiducial markers, Pet and MRI<br>* Insertion of Fiducial markers in esophageal wall.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify motion of the esophageal tumor over the course of chemoradiation | The outcome measures will be assessed by tracking the motion of the fiducial markers at the daily 4D CBCT (four dimensional cone beam CT scan). (primary outcome) By observing the motion of the fiducial, the exact setup error, breathing motion amplitudes, intra- and inter-fraction motion can be assessed. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemoradiation, Esophageal cancer