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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01023633

Enrollment

300

Registered

2009-12-02

Start date

2009-10-31

Completion date

2015-07-31

Last updated

2009-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGOxaliplatin, LV, 5-FU

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
DDC: Duration of Disease Control	Oct2012

Secondary

Measure	Time frame
OS, RR, PFS, DCR, safety,	Oct 2015

Countries

China

Contacts

Primary ContactYongqian Shu, MD

shuyongqian@csco.org.cn86 25 83718836

Backup ContactXiaofeng Chen, MD

xiaofengch198019@126.com86 25 83718836

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026