Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Study Overview
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Brief Summary
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Stage I：preoperative therapy Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone; A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer

Official Title
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Phase II Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Concurrent Radiotherapy in Patients With Potentially Resectable Adenocarcinoma of Gastroesophageal Cancer

Conditions
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Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Drug: Oxaliplatin; Capecitabine
* Other: Oxaliplatin; Capecitabine; concurrent radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria) Histologically confirmed primary adenocarcinoma T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0， ECOG performance status ≦2 AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia. The classification of AEG type I, type II and type III AEG type I: adenocarcinoma of the distal esophagus,which usually arises from an area with specialized intestinal metaplasia of the esophagus, i Barrett's esophagus, and may infiltrate the esophago-gastric junction from above; AEG type II: true carcinoma of the cardia, arising from the cardia epithelium or short segments with intestinal metaplasia at the esophago-gastric junction; AEG type III: subcardial gastric carcinoma, which infiltrates the esophago-gastric junction and distal esophagus from below. Exclusion Criteria: Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning. Patients with primary carcinomas of the esophagus. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery. Patients with evidence of metastatic disease are not eligible. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements. Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study. History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postoperative chemotherapy,XELOX<br> | Drug: Oxaliplatin; Capecitabine<br>* Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation<br>* Other names: Oxaliplatin;|
| Experimental: Preoperative Concurrent Chemoradiotherapy<br> | Other: Oxaliplatin; Capecitabine; concurrent radiotherapy<br>* Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT<br>* Other names: XRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival(DFS) |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0-resection rate |  | within 3 weeks after surgery | 
| Objective response rate (ORR) |  | within 3 weeks after surgery | 
| Disease control rate (DCR) |  | within 3 weeks after surgery | 
| Down-staging Rate |  | within 3 weeks after surgery | 
| Overall survival (OS) |  | 3years | 
| Adverse events | Side effects during observation] Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit. | 3 year | 
| Death related to operation |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capecitabine, Oxaliplatin, Preoperative Concurrent Chemoradiotherapy, Gastroesophageal Junction Adenocarcinoma