Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Phase 3

Not yet recruiting

• Conditions: Esophagogastric Junction Disorder; Neoplasms
• Interventions: Radiation: chemoradiation with weekly 5Fu and oxaliplatin; Drug: Perioperative mFLOT; Drug: Perioperative FOLFOX

• Registration Number: NCT03961841
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-23
• Study Start: 2020-06
• Primary Completion: 2024-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• informed consensus of the enrolled patients
• from 18 to 75 years old
• proven to be primary adenocarcinoma of EGJ
• pre-operative staging cT3-4N+M0
• no prior other chemotherapy and/or radiation against the disease
• normal function of all other vital organs including heart,liver ,kidney and so on
• Eastern Cooperative Oncology Group performance status: 0~2

Exclusion Criteria

• history of other malignancy
• allergic reaction to capecitabine or oxaliplatin
• enrolled in other clinical trials
• abnormal GI tract function
• dysfunction of other organs
• pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
• other situations judged as not adaptive to the study by investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiation	chemoradiation with weekly 5Fu and oxaliplatin	weekly 5-Fu and oxaliplatin
FLOT	Perioperative mFLOT	Eight perioperative chemotherapy cycles
FOLFOX	Perioperative FOLFOX	Twelve perioperative chemotherapy cycles

Primary Outcome Measures

Name	Time	Method
3 year of disease free survival	3 year

Secondary Outcome Measures

Name	Time	Method
5 year of overall survival	5 year
Rate of pathological complete remission	1 year
Anastomosis leak rate	1 year