OPTIMOX1 in Chinese mCRC Patients
- Conditions
- Colorectal Cancer
- Interventions
- Drug: Oxaliplatin, LV, 5-FU
- Registration Number
- NCT01023633
- Lead Sponsor
- Nanjing Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU) Oxaliplatin, LV, 5-FU The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles. Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU) 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
- Primary Outcome Measures
Name Time Method DDC: Duration of Disease Control Oct2012
- Secondary Outcome Measures
Name Time Method OS, RR, PFS, DCR, safety, Oct 2015
Trial Locations
- Locations (2)
Zhejiang University affiliated sir run run shaw hospital
🇨🇳HangZhou, Zhejiang, China
The 1st Affiliated Hospital Of NanJing Medical University
🇨🇳Nanjing, Jiangsu, China