Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction
Conditions
Gastroesophageal Junction Adenocarcinoma
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms
Conditions: Keywords
Capecitabine, Oxaliplatin, Preoperative Concurrent Chemoradiotherapy, Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin; Capecitabine Type: Drug
Name: Oxaliplatin; Capecitabine; concurrent radiotherapy Type: Other
Overall Status
Recruiting
Summary
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria)

2. Histologically confirmed primary adenocarcinoma

3. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0,

4. 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:

1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.

2. Patients with primary carcinomas of the esophagus.

3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.

4. Patients with evidence of metastatic disease are not eligible.

5. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.

6. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.

7. 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.

8. History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product -
Location
Department of General Surgery
Shijiazhuang, Hebei, China
Status: Recruiting
Contact: Qun Zhao, Doctor - +8613930162111 - zhaoqun516@yahoo.com.cn
Start Date
February 2012
Completion Date
December 2018
Sponsors
Hebei Medical University
Source
Hebei Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page