OPTIMOX1 in Chinese mCRC Patients
A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 colorectal-cancer
Started Oct 2009
Longer than P75 for phase_4 colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 2, 2009
December 1, 2009
4.3 years
December 1, 2009
December 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DDC: Duration of Disease Control
Oct2012
Secondary Outcomes (1)
OS, RR, PFS, DCR, safety,
Oct 2015
Study Arms (2)
Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)
ACTIVE COMPARATORThe 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)
EXPERIMENTALThe arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The 1st Affiliated Hospital Of NanJing Medical University
Nanjing, Jiangsu, 210029, China
Zhejiang University affiliated sir run run shaw hospital
Hangzhou, Zhejiang, 310016, China
Related Publications (1)
Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.
PMID: 16421419RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 2, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2014
Study Completion
July 1, 2015
Last Updated
December 2, 2009
Record last verified: 2009-12