Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophagogastric Junction Disorder, Neoplasms

Intervention / Treatment
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* Radiation: chemoradiation with weekly 5Fu and oxaliplatin
* Drug: Perioperative mFLOT
* Drug: Perioperative FOLFOX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year of disease free survival |  | 3 year | 

Secondary Outcome Measures

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