A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- DDC: Duration of Disease Control
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)
The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles.
Intervention: Oxaliplatin, LV, 5-FU (Drug)
Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)
The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles
Intervention: Oxaliplatin, LV, 5-FU (Drug)
Outcomes
Primary Outcomes
DDC: Duration of Disease Control
Time Frame: Oct2012
Secondary Outcomes
- OS, RR, PFS, DCR, safety,(Oct 2015)