mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy

Metastatic Colorectal Cancer Clinical Trial

Official title:

mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy（NEW RECHALLENGE）- A Multicenter Open Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362617
• Other study ID #: NRE202001
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan, MD,PHD
• Phone: 13858193601
• Email: yuanying1999[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter,open,prospective randomized controlled trial;11 study center in China; Plan to enroll 328 patients（ Power Analysis and Sample Size ）.Comparing FOLFIRI with mFOLFOX6,Superiority design.Investigate difference PFS,ORR,R0 resection rate,OS ,QoL and Safety from two regimens Stratification factors : Analyzing patients recurrence within 6-12months,and 12-18months .Obtain definite chemotherapy regimen shift opportunity for patients recurrence/metastasis after adjuvant chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

18-75 years,male or female Colorectal adenocarcinoma Accepting more than 4 cycles oxaplatin based adjuvant chemotherapy after radical operation Reccurrence in 6-18 months after adjuvant chemotherapy At least one assessable lesions No intestinal obstruction ECOG 0-1 Estimated survival= 3 months CBC:WBC>4×109/L,PLT>80×109/L,Hb>90g/L, Liver function:ALT or AST < 2× normal maximum value, T-bile<1.5× normal maximum value without hepatic metastatic, ALT or AST < 5× normal maximum value, T-bile<1.5× normal maximum value with hepatic metastatic Cr<1.8mg/dl Signed informed consent

Exclusion Criteria:

Locally resectable lesions Grade 2-4 oxaliplatin induced neurotoxicity Arrhythmias,coronary heart disease,or congestive heart failure(NYHA=grade 2) requiring treatment Poorly controlled hypertension HIV infected or active HBV or HCV infected Active serious infection Cachexia or organ function decompensation Multiple primary carcinoma except carcinoma in situ of skin and cervix Participate in other clinical studies at the same time Serious heart or brain disease Drug abuse or other serious psychosocial diseases Suspected trial drug allergy Other factors affecting patient safety and compliance Pregnant or lactating women,or fertility without adequate contraceptive measures

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer
• Recurrence

Intervention

Drug:
• FOLFIRI
FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy

Locations

Country	Name	City	State
China	SAHZU	Hangzhou	Zhejinag

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(objective response rate)	imaging evaluation	At the end of Cycle 3(6 weeks after first chemotherapy)
Secondary	PFS	imaging evaluation PD	At the end of Cycle 6(each cycle is 14 days)
Secondary	OS	patient death	At the end of Cycle 12(each cycle is 14 days)
Secondary	R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate	sugery	At the end of Cycle 12(each cycle is 14 days)
Secondary	QoL(quality of life)	Life state	At the end of Cycle 12