OPTIMOX1 in Chinese mCRC Patients

Study Overview
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Brief Summary
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Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 for another 6 cycles (arm B). Data showed that there was no significant difference in median progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to investigate the efficacy and feasibility of the novel Stop and go strategy in Chinese mCRC patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4 regimen is chosen in this study.

Official Title
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A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Oxaliplatin, LV, 5-FU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed adenocarcinoma of the colon or rectum Unresectable metastases At least one bidimensionally measurable lesion of ≥ 1 cm No previous chemotherapy for metastatic disease; Completed at least more than 1 year oxaliplatin therapy for adjuvant treatment 18-75 years old ECOG 0-2 Life expectancy greater than 3 months Hemogram: WBC≥4.0 X109/L, ANC ≥2 X109/L, PLT ≥100 X109/L, Hb ≥90g/L, Adequate Renal Function Adequate Liver Function Signed informed consent before the treatment Exclusion Criteria: Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year Completely or partially bowel obstruction Presence of peripheral neuropathy (CTC>grade I) Severe mental disorder CNS metastasis With other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina With other malignant disease previously or concurrently Receive other anti-tumor treatment Pregnant or lactating women, or women of child bearing potential without contraceptive method.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)<br>The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles. | Drug: Oxaliplatin, LV, 5-FU<br>* Arm B(Intervention arm) will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles. FOLFOX4 regimen: OXA 85mg/m2 , 2 hour infusion, d1 , Leucovorin 200 mg/m2 plus 5-FU 400mg IV bolus, then continuous 22 hour 600 mg/m2 infusion on day 1 and 2 Q2W<br>* Other names: Eloxatin;|
| Experimental: Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)<br>The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles | Drug: Oxaliplatin, LV, 5-FU<br>* Arm B(Intervention arm) will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles. FOLFOX4 regimen: OXA 85mg/m2 , 2 hour infusion, d1 , Leucovorin 200 mg/m2 plus 5-FU 400mg IV bolus, then continuous 22 hour 600 mg/m2 infusion on day 1 and 2 Q2W<br>* Other names: Eloxatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DDC: Duration of Disease Control |  | Oct2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS, RR, PFS, DCR, safety, |  | Oct 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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to investigate the efficacy and feasibility of this novel treatment strategy in Chinese mCRC patients, Primary Endpoint:DDC, Secondary Endpoint:OS, RR,DCR, PFS,safety