IPO-NEC Trial:Study on the Efficacy and Safety Using Sequential IP Therapy and Oct Lar in the Treatment of Advanced GI NEC
- Sponsor
- Peking University
- Study ID
- NCT01480986
- Phase
- PHASE2
- Status
- Completed
Conditions
- Progression Free Survival of the Treatment
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan combined with cisplatin, octreotide lar — DRUGPhase 1 irinotecan 180mg/m\^2，ivgtt，90min，D1 Cisplatin 50 mg/m\^2，ivgtt，120min，D1（with hydration） Phase 2 Octreotide 0.1mg，ih，q8h，D1-14 Octreotide lar 20mg，deep i.m，D8，
Study Details
This is a prospective, single-armed, open label study on the efficacy and safety of sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished without disease progression or progression occurs during the treatment, the patient will enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint is progression free survival in the two steps respectively and secondary endpoint is disease control rate, overall survival and safety
Key Dates
- Start date
- Sep 30, 2011
- Status verified
- May 2015
- Primary completion
- Sep 30, 2012
- Completion
- Dec 31, 2013
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment armThis is a single arm trial. The patient will enter phase one and will continue to phase two once the disease progresses in phase one or the phase one has been completed.
Primary Outcome Measure
Progression Free Survival for Irinotecan plus cisplatin and octreotide [ Time Frame: 2 years ]