Clinical trial · Interventional
mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy
mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy（NEW RECHALLENGE）- A Multicenter Open Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFIRI
- description
- 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
- interventionNames
- Drug: FOLFIRI
- type
- ACTIVE_COMPARATOR
- label
- mFOLFOX6
- description
- 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
- interventionNames
- Drug: FOLFIRI
Primary outcomes (1)
- measure
- ORR（objective response rate）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available