Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

December 19, 2019 updated by: Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Chemoradiation
weekly 5-Fu and oxaliplatin
Radiation: chemoradiation with weekly 5Fu and oxaliplatin
5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week
EXPERIMENTAL: FLOT
Eight perioperative chemotherapy cycles
Drug: Perioperative mFLOT
Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
EXPERIMENTAL: FOLFOX
Twelve perioperative chemotherapy cycles
Drug: Perioperative FOLFOX
Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 year of disease free survival
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
5 year of overall survival
Time Frame: 5 year
5 year
Rate of pathological complete remission
Time Frame: 1 year
1 year
Anastomosis leak rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2024

Study Completion (ANTICIPATED)

August 1, 2029

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (ACTUAL)

May 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHMO202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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