Clinical trial NCT01023633: OPTIMOX1 in Chinese mCRC Patients
Official title: A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: 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
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: DDC: Duration of Disease Control
timeFrame: Oct2012
Secondary outcomes:
measure: OS, RR, PFS, DCR, safety,
timeFrame: Oct 2015
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The 1st Affiliated Hospital Of NanJing Medical University
state: Jiangsu
city: HangZhou
country: China
facility: Zhejiang University affiliated sir run run shaw hospital
state: Zhejiang
Study officials:
References:
citation: 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.