A-C: Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Sponsor

Hebei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT01962246

Collaborator

(none)

169

Enrollment

Location

Arms

114

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Junction Adenocarcinoma	Drug: Oxaliplatin; Capecitabine Other: Oxaliplatin; Capecitabine; concurrent radiotherapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

169 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: postoperative chemotherapy,XELOX	Drug: Oxaliplatin; Capecitabine Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation Other Names: Xeloda Oxaliplatin
Experimental: Preoperative Concurrent Chemoradiotherapy	Other: Oxaliplatin; Capecitabine; concurrent radiotherapy 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 Other Names: Xeloda Oxaliplatin XRT

Arm

Intervention/Treatment

Active Comparator: postoperative chemotherapy,XELOX

Drug: Oxaliplatin; Capecitabine

Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation

Other Names:

Xeloda

Oxaliplatin

Experimental: Preoperative Concurrent Chemoradiotherapy

Other: Oxaliplatin; Capecitabine; concurrent radiotherapy

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

Other Names:

Xeloda

Oxaliplatin

XRT

Outcome Measures

Primary Outcome Measures

Disease-free survival(DFS) [3 year]

Secondary Outcome Measures

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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 -