OPTIMOX1 in Chinese mCRC Patients

NCT ID: NCT01023633

Last Updated: 2009-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-07-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oxaliplatin, LV, 5-FU

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Oxaliplatin, LV, 5-FU

Intervention Type: DRUG

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

Interventions

Oxaliplatin, 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

Intervention Type: DRUG

Other Intervention Names

Eloxatin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nanjing Medical University

Locations

The 1st Affiliated Hospital Of NanJing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Zhejiang University affiliated sir run run shaw hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongqian Shu, MD

Role: CONTACT

shuyongqian@csco.org.cn

86 25 83718836 ext. 6428

Xiaofeng Chen, MD

Role: CONTACT

xiaofengch198019@126.com

86 25 83718836 ext. 6428

Facility Contacts

Xiaofeng Chen, MD

Role: primary

xiaofengch198019@126.com

86 25 83718836 ext. 6428

Hongming Pan, MD

Role: primary

panhongming@tom.com

0571-86090073

References

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.

Reference Type: RESULT

PMID: 16421419 (View on PubMed)

Other Identifiers

Oxali04882

Identifier Type: -

Identifier Source: org_study_id