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

Primary Purpose

Gastroesophageal Junction Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Oxaliplatin; Capecitabine

Oxaliplatin; Capecitabine; concurrent radiotherapy

About this trial

This is an interventional treatment trial for Gastroesophageal Junction Adenocarcinoma focused on measuring Capecitabine, Oxaliplatin, Preoperative Concurrent Chemoradiotherapy, Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

Department of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

postoperative chemotherapy,XELOX

Preoperative Concurrent Chemoradiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival(DFS)

Secondary Outcome Measures

R0-resection rate

Objective response rate (ORR)

Disease control rate (DCR)

Down-staging Rate

Overall survival (OS)

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.

Death related to operation

Full Information

NCT ID

NCT01962246

First Posted

July 22, 2012

Last Updated

February 4, 2022

Sponsor

Hebei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01962246

Brief Title

Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Acronym

A-C

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 Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2020 (Actual)

Study Completion Date

August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Junction Adenocarcinoma

Keywords

Capecitabine, Oxaliplatin, Preoperative Concurrent Chemoradiotherapy, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

postoperative chemotherapy,XELOX

Arm Type

Active Comparator

Arm Title

Preoperative Concurrent Chemoradiotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin; Capecitabine

Other Intervention Name(s)

Xeloda, Oxaliplatin

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Oxaliplatin; Capecitabine; concurrent radiotherapy

Other Intervention Name(s)

Xeloda, Oxaliplatin, XRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease-free survival(DFS)

Time Frame

3 year

Secondary Outcome Measure Information:

Title

R0-resection rate

Time Frame

within 3 weeks after surgery

Title

Objective response rate (ORR)

Time Frame

within 3 weeks after surgery

Title

Disease control rate (DCR)

Time Frame

within 3 weeks after surgery

Title

Down-staging Rate

Time Frame

within 3 weeks after surgery

Title

Overall survival (OS)

Time Frame

3years

Title

Adverse events

Description

Time Frame

3 year

Title

Death related to operation

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qun Zhao, Doctor

Organizational Affiliation

Hebei Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of General Surgery

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050011

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34858829

Citation

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.

Results Reference

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Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

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