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OPTIMOX1 in Chinese mCRC Patients

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ClinicalTrials.gov Identifier: NCT01023633
Recruitment Status : Unknown
Verified December 2009 by Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Oxaliplatin, LV, 5-FU Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer
Study Start Date : October 2009
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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

Other Name: Eloxatin

Experimental: 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
Drug: 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

Other Name: Eloxatin




Primary Outcome Measures :
  1. DDC: Duration of Disease Control [ Time Frame: Oct2012 ]

Secondary Outcome Measures :
  1. OS, RR, PFS, DCR, safety, [ Time Frame: Oct 2015 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023633


Contacts
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Contact: Yongqian Shu, MD 86 25 83718836 ext 6428 shuyongqian@csco.org.cn
Contact: Xiaofeng Chen, MD 86 25 83718836 ext 6428 xiaofengch198019@126.com

Locations
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China, Jiangsu
The 1st Affiliated Hospital Of NanJing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Xiaofeng Chen, MD    86 25 83718836 ext 6428    xiaofengch198019@126.com   
Principal Investigator: Yongqian Shu, MD         
China, Zhejiang
Zhejiang University affiliated sir run run shaw hospital Recruiting
HangZhou, Zhejiang, China, 310016
Contact: Hongming Pan, MD    0571-86090073    panhongming@tom.com   
Principal Investigator: Hongming Pan, MD         
Sponsors and Collaborators
Nanjing Medical University

Publications of Results:
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Responsible Party: Nanjing Medical University., Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01023633     History of Changes
Other Study ID Numbers: Oxali04882
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

Keywords provided by Nanjing Medical University:
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

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents