Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Phase 2

Completed

• Conditions: Gastroesophageal Junction Adenocarcinoma
• Interventions: Other: Oxaliplatin; Capecitabine; concurrent radiotherapy; Drug: Oxaliplatin; Capecitabine

• Registration Number: NCT01962246
• Lead Sponsor: Hebei Medical University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-07-22
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Primary Completion: 2020-02
• Study Completion: 2021-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative Concurrent Chemoradiotherapy	Oxaliplatin; Capecitabine; concurrent radiotherapy	-
postoperative chemotherapy,XELOX	Oxaliplatin; Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival(DFS)	3 year

Secondary Outcome Measures

Name	Time	Method
R0-resection rate	within 3 weeks after surgery
Down-staging Rate	within 3 weeks after surgery
Adverse events	3 year	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.
Death related to operation	4 weeks
Objective response rate (ORR)	within 3 weeks after surgery
Overall survival (OS)	3years
Disease control rate (DCR)	within 3 weeks after surgery

Trial Locations

Locations (1)

Department of General Surgery; 🇨🇳 Shijiazhuang, Hebei, China