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Completed

NCT Number: NCT01962246

Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of General Surgery

Shijiazhuang, Hebei, 050011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Oxaliplatin; Capecitabine

Drug

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

Other names: Xeloda, Oxaliplatin

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

Other names: Xeloda, Oxaliplatin, XRT

Primary outcomes

  1. Disease-free survival(DFS)

    Time frame: 3 year

Secondary outcomes

  1. R0-resection rate

    Time frame: within 3 weeks after surgery

  2. Objective response rate (ORR)

    Time frame: within 3 weeks after surgery

  3. Disease control rate (DCR)

    Time frame: within 3 weeks after surgery

  4. Down-staging Rate

    Time frame: within 3 weeks after surgery

  5. Overall survival (OS)

    Time frame: 3years

  6. Adverse events

    Time frame: 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.

  7. Death related to operation

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Official study title

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

Acronym: A-C

Important dates

Study start
2012
Primary completion
2020
Study completion
2021
First posted
Oct 14, 2013
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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