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OPTIMOX1 in Chinese mCRC Patients

N

Nanjing Medical University

Status and phase

Unknown
Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: Oxaliplatin, LV, 5-FU

Study type

Interventional

Funder types

Other

Identifiers

NCT01023633
Oxali04882

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)
Active Comparator group
Description:
The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles.
Treatment:
Drug: Oxaliplatin, LV, 5-FU
Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)
Experimental group
Description:
The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles
Treatment:
Drug: Oxaliplatin, LV, 5-FU

Trial contacts and locations

2

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Central trial contact

Xiaofeng Chen, MD; Yongqian Shu, MD

Data sourced from clinicaltrials.gov

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