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OPTIMOX1 in Chinese mCRC Patients

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin, LV, 5-FU
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The 1st Affiliated Hospital Of NanJing Medical UniversityRecruiting
  • Zhejiang University affiliated sir run run shaw hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)

Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)

Arm Description

The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles.

The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles

Outcomes

Primary Outcome Measures

DDC: Duration of Disease Control

Secondary Outcome Measures

OS, RR, PFS, DCR, safety,

Full Information

First Posted
December 1, 2009
Last Updated
December 1, 2009
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01023633
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)
Arm Type
Active Comparator
Arm Description
The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles.
Arm Title
Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)
Arm Type
Experimental
Arm Description
The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, LV, 5-FU
Other Intervention Name(s)
Eloxatin
Intervention Description
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
Primary Outcome Measure Information:
Title
DDC: Duration of Disease Control
Time Frame
Oct2012
Secondary Outcome Measure Information:
Title
OS, RR, PFS, DCR, safety,
Time Frame
Oct 2015

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongqian Shu, MD
Phone
86 25 83718836
Ext
6428
Email
shuyongqian@csco.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Chen, MD
Phone
86 25 83718836
Ext
6428
Email
xiaofengch198019@126.com
Facility Information:
Facility Name
The 1st Affiliated Hospital Of NanJing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Chen, MD
Phone
86 25 83718836
Ext
6428
Email
xiaofengch198019@126.com
First Name & Middle Initial & Last Name & Degree
Yongqian Shu, MD
Facility Name
Zhejiang University affiliated sir run run shaw hospital
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan, MD
Phone
0571-86090073
Email
panhongming@tom.com
First Name & Middle Initial & Last Name & Degree
Hongming Pan, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16421419
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.
Results Reference
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OPTIMOX1 in Chinese mCRC Patients

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