Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Gastroesophageal Junction Adenocarcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962246
• Other study ID #: Alien-Craft
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2012
• Est. completion date: August 2021

Study information

• Verified date: February 2022
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: August 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Disease must be clinically limited to the esophagogastric junction, defined Type? Type?(From the endoscopic point of view according to the AEG criteria)

2. Histologically confirmed primary adenocarcinoma

3. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0,

4. 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:

1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.

2. Patients with primary carcinomas of the esophagus.

3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.

4. Patients with evidence of metastatic disease are not eligible.

5. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.

6. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.

7. 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.

8. History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product -

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastroesophageal Junction Adenocarcinoma

Intervention

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

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

Locations

Country	Name	City	State
China	Department of General Surgery	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival(DFS)		3 year
Secondary	R0-resection rate		within 3 weeks after surgery
Secondary	Objective response rate (ORR)		within 3 weeks after surgery
Secondary	Disease control rate (DCR)		within 3 weeks after surgery
Secondary	Down-staging Rate		within 3 weeks after surgery
Secondary	Overall survival (OS)		3years
Secondary	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.	3 year
Secondary	Death related to operation		4 weeks