CompletedNCT01962246A-CUpdated Feb 21, 2022

Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

A Phase 2/3 interventional study of Oxaliplatin; Capecitabine and Oxaliplatin; Capecitabine; concurrent radiotherapy in Gastroesophageal Junction Adenocarcinoma, sponsored by Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-21.

Sponsored by Hebei Medical University · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 169
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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

Conditions studied

Gastroesophageal Junction Adenocarcinoma

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Keywords

Capecitabine
Oxaliplatin
Preoperative Concurrent Chemoradiotherapy
Gastroesophageal Junction Adenocarcinoma

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 169 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

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Lead sponsor

Hebei Medical University is the lead sponsor of 39 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 -

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 169 participants (actual)

Study arms

Active comparator
postoperative chemotherapy,XELOX
Drug: Oxaliplatin; Capecitabine
Experimental
Preoperative Concurrent Chemoradiotherapy
Other: Oxaliplatin; Capecitabine; concurrent radiotherapy

Interventions

DrugOxaliplatin; Capecitabine
Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation
Also known as: Xeloda, Oxaliplatin
OtherOxaliplatin; 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
Also known as: Xeloda, Oxaliplatin, XRT

What researchers measure

Primary outcomes

Disease-free survival(DFS)
Time frame: 3 year

Secondary outcomes

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

Study locations

1 site

Department of General Surgery
Shijiazhuang, Hebei 050011, China

References and documents

Publications

Tian Y, Wang J, Qiao X, Zhang J, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Yang P, Zhao Q. Long-Term Efficacy of Neoadjuvant Concurrent Chemoradiotherapy for Potentially Resectable Advanced Siewert Type II and III Adenocarcinomas of the Esophagogastric Junction. Front Oncol. 2021 Nov 11;11:756440. doi: 10.3389/fonc.2021.756440. eCollection 2021. PubMed 34858829 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01962246
Lead sponsor: Hebei Medical University
Responsible party: Qun Zhao (Principal Investigator, Hebei Medical University) — Principal investigator
First posted: Oct 14, 2013
Start date: Feb 2012
Primary completion: Feb 2020
Completion: Aug 2021
Last update: Feb 21, 2022

Study contacts

Qun Zhao, Doctor

principal investigator · Hebei Medical University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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