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Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

NCT ID: NCT03961841

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2029-08-31

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.

Detailed Description

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Conditions

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Esophagogastric Junction Disorder Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemoradiation

weekly 5-Fu and oxaliplatin

Group Type ACTIVE_COMPARATOR

chemoradiation with weekly 5Fu and oxaliplatin

Intervention Type RADIATION

5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week

FLOT

Eight perioperative chemotherapy cycles

Group Type EXPERIMENTAL

Perioperative mFLOT

Intervention Type DRUG

Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles

FOLFOX

Twelve perioperative chemotherapy cycles

Group Type EXPERIMENTAL

Perioperative FOLFOX

Intervention Type DRUG

Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles

Interventions

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chemoradiation with weekly 5Fu and oxaliplatin

5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week

Intervention Type RADIATION

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

Intervention Type DRUG

Perioperative FOLFOX

Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Jian Xiao

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shanshan Li, MD

Role: CONTACT

Phone: 86-20-38285497

Email: [email protected]

Xiaohui Zhai, MD

Role: CONTACT

Phone: 86-20-38285497

Email: [email protected]

Other Identifiers

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SAHMO202

Identifier Type: -

Identifier Source: org_study_id