Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

NCT03961841 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SAHMO202
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophagogastric Junction Disorder; Neoplasms

Outcome Measures

Primary Outcomes (1)

• 3 year of disease free survival

  3 year

Secondary Outcomes (3)

• 5 year of overall survival

  5 year

• Rate of pathological complete remission

  1 year

• Anastomosis leak rate

  1 year

Study Arms (3)

Chemoradiation

ACTIVE COMPARATOR

weekly 5-Fu and oxaliplatin

Radiation: chemoradiation with weekly 5Fu and oxaliplatin

FLOT

EXPERIMENTAL

Eight perioperative chemotherapy cycles

Drug: Perioperative mFLOT

FOLFOX

EXPERIMENTAL

Twelve perioperative chemotherapy cycles

Drug: Perioperative FOLFOX

Interventions

chemoradiation with weekly 5Fu and oxaliplatin RADIATION

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

Chemoradiation

Perioperative mFLOT DRUG

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

FLOT

Perioperative FOLFOX DRUG

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

FOLFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Chemoradiotherapy; Oxaliplatin

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Coordination Complexes; Organic Chemicals

Central Study Contacts

Shanshan Li, MD

CONTACT

86-20-38285497; lishsh89@163.com

Xiaohui Zhai, MD

CONTACT

86-20-38285497; zhaixh@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: June 1, 2020
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share