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

NCT05362617 | Unknown Phase 3

• 1 other identifier: NRE202001
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancer; Completion of adjuvant therapy; First line chemotherapy

Outcome Measures

Primary Outcomes (1)

• ORR（objective response rate）

  imaging evaluation

  At the end of Cycle 3（6 weeks after first chemotherapy）

Secondary Outcomes (4)

• PFS

  At the end of Cycle 6(each cycle is 14 days)

• OS

  At the end of Cycle 12(each cycle is 14 days)

• R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate

  At the end of Cycle 12(each cycle is 14 days)

• QoL（quality of life）

  At the end of Cycle 12

Study Arms (2)

FOLFIRI

EXPERIMENTAL

Irinotecan 180 mg/m2 I.V 30-90 min，D1； LV 400 mg/m2 I.V.，D1； 5-FU 400 mg/m2 IVP，d1,1200 mg/m2/d×2 days（Total:2400 mg/m2，Continuous intravenous infusion,46\~48 hours,） Repeat Every 14 days

Drug: FOLFIRI

mFOLFOX6

ACTIVE COMPARATOR

Oxaplatin 85 mg/m2 I.V 120 min，D1； LV 400 mg/m2 I.V.，D1； 5-FU 400 mg/m2 IVP，d1,1200 mg/m2/d×2 days（Total:2400 mg/m2，Continuous intravenous infusion,46\~48 hours,） Repeat Every 14 days

Drug: FOLFIRI

Interventions

FOLFIRI DRUG

FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy

FOLFIRI; mFOLFOX6

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

SAHZU

Hangzhou, Zhejinag, 310009, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Ying Yuan, MD,PHD

CONTACT

13858193601; yuanying1999@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: SPONSOR

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: May 5, 2022
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 5, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)