Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

NCT01962246 | Completed Phase 2

• 1 other identifier: Alien-Craft
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroesophageal Junction Adenocarcinoma

Keywords

Capecitabine; Oxaliplatin; Preoperative Concurrent Chemoradiotherapy; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival(DFS)

  3 year

Secondary Outcomes (7)

• 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

Study Arms (2)

postoperative chemotherapy,XELOX

ACTIVE COMPARATOR

Drug: Oxaliplatin; Capecitabine

Preoperative Concurrent Chemoradiotherapy

EXPERIMENTAL

Other: Oxaliplatin; Capecitabine; concurrent radiotherapy

Interventions

Oxaliplatin; Capecitabine DRUG

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

Also known as: Xeloda, Oxaliplatin

postoperative chemotherapy,XELOX

Oxaliplatin; Capecitabine; concurrent radiotherapy OTHER

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

Preoperative Concurrent Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

Department of General Surgery

Shijiazhuang, Hebei, 050011, China

Location

Related Publications (1)

• 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.

  PMID: 34858829 DERIVED

MeSH Terms

Interventions

Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Qun Zhao, Doctor

  Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2012
• First Posted: October 14, 2013
• Study Start: February 1, 2012
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

CN (1)