Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03961841
• Other study ID #: SAHMO202
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2020
• Est. completion date: August 2029

Study information

• Verified date: December 2019
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Shanshan Li, MD
• Phone: 86-20-38285497
• Email: lishsh89[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: August 2029
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophagogastric Junction Disorder
• Neoplasms

Intervention

Radiation:
• chemoradiation with weekly 5Fu and oxaliplatin
5Fu 225 mg/m2 IV daily continuous infusion;oxaliplatin 40 mg/m2/week

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year of disease free survival		3 year
Secondary	5 year of overall survival		5 year
Secondary	Rate of pathological complete remission		1 year
Secondary	Anastomosis leak rate		1 year