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OPTIMOX1 in Chinese mCRC Patients

NCT ID: NCT01023633

Last Updated: 2009-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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Conditions

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Colorectal Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Eloxatin

Eligibility Criteria

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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

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Medical University

Locations

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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

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China

Central Contacts

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Yongqian Shu, MD

Role: CONTACT

Phone: 86 25 83718836

Email: [email protected]

Xiaofeng Chen, MD

Role: CONTACT

Phone: 86 25 83718836

Email: [email protected]

Facility Contacts

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Xiaofeng Chen, MD

Role: primary

Hongming Pan, MD

Role: primary

References

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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

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Oxali04882

Identifier Type: -

Identifier Source: org_study_id