OPTIMOX1 in Chinese mCRC Patients

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Medical University
• Treatments: Oxaliplatin

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.