Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 3

Conditions: Neoplasms; Esophagogastric Junction Disorder

Treatments: Drug: Perioperative FOLFOX; Radiation: chemoradiation with weekly 5Fu and oxaliplatin; Drug: Perioperative mFLOT

Study type: Interventional

Funder types: Other

Identifiers

NCT03961841

SAHMO202

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Chemoradiation

Active Comparator group

Description:

weekly 5-Fu and oxaliplatin

Treatment:

Radiation: chemoradiation with weekly 5Fu and oxaliplatin

FLOT

Experimental group

Description:

Eight perioperative chemotherapy cycles

Treatment:

Drug: Perioperative mFLOT

FOLFOX

Experimental group

Description:

Twelve perioperative chemotherapy cycles

Treatment:

Drug: Perioperative FOLFOX