Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Phase 2

• Conditions: Gastroesophageal Junction Adenocarcinoma
• Interventions: Radiation: Preoperative concurrent chemoradiotherapy; Procedure: Radical D2 total gastrectomy; Drug: Adjuvant chemotherapy

• Registration Number: NCT02193594
• Lead Sponsor: Peking University

Brief Summary

Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08
• Primary Completion: 2017-09
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Histologically proven adenocarcinoma of the gastroesophageal junction.
• Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
• Eastern Cooperative Oncology Group (ECOG) performance status≤2.
• Informed consent obtained.

Exclusion Criteria

• Combined with other malignant tumors.
• Eastern Cooperative Oncology Group (ECOG) performance status>2.
• Combined with severe organ dysfunction.
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCRT group	Adjuvant chemotherapy	The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
CCRT group	Preoperative concurrent chemoradiotherapy	The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
CCRT group	Radical D2 total gastrectomy	The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.
CT group	Radical D2 total gastrectomy	The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.
CT group	Adjuvant chemotherapy	The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.

Primary Outcome Measures

Name	Time	Method
The patient's survival time and recurrence time	Up to 3 years	3-year overall survival; 1-year and 3-year recurrence free survival

Secondary Outcome Measures

Name	Time	Method
The number of patients with complications	Within 30 days after the day of operation	the morbidity and mortality rates within 30 days after the day of operation

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Haidian District, Beijing, China