Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.

Study Overview
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Brief Summary
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In this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. Primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement.

Official Title
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Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.

Conditions
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Adenocarcinoma of the Esophagus or Esophagogastric Junction

Intervention / Treatment
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* Radiation: Radiation therapy
* Drug: Oxaliplatin and fluorouracil.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent Any T, N and M Age: 18 years or older WHO performance status ≤ 2 Life expectancy > 3 months Dysphagia score > 0 Adequate laboratory findings: hemoglobin > 90 g/L, absolute neutrophil count 1.0 10 9/L, platelets ≥ 75 x 10 9/L, bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN, creatinine ≤ 1.5 x ULN Fertile men and women must use effective means of contraception Signed written informed concent The patient must be able to comply with the protocol Exclusion Criteria: Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months) unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure Severe pulmonary disease e.g. pulmonary fibrosis Symptomatic peripheral neuropathy greater than grade 1 (CTCAE v. 4.0) Known hypersensitivity to any contents of the study drugs Pregnancy ( positive pregnancy test) and/or breast feeding Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial

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: Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).<br>Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2. | Radiation: Radiation therapy<br>* Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.<br>Drug: Oxaliplatin and fluorouracil.<br>* Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of dysphagia. | The rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an approvement. | The grade of dysphagia is evaluated before start of treatment, 1-4 weeks after end of radiotherapy, then until local intervention or death, average of 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic response of the primary tumor. |  | Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digestive System Diseases, Esophageal cancer, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Endoscopic response, Fluorouracil, Metabolic response, Oxaliplatin, Radiotherapy