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IPO-NEC Trial:Study on the Efficacy and Safety Using Sequential IP Therapy and Oct Lar in the Treatment of Advanced GI NEC

NCT01480986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-19

No results posted yet for this study

Summary

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

Conditions

  • Progression Free Survival of the Treatment

Interventions

DRUG

Irinotecan combined with cisplatin, octreotide lar

Phase 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，

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-09-30
Completion
2013-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01480986 on ClinicalTrials.gov