IPO-NEC Trial:Study on the Efficacy and Safety Using Sequential IP Therapy and Oct Lar in the Treatment of Advanced GI NEC
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|ClinicalTrials.gov Identifier: NCT01480986|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : May 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Progression Free Survival of the Treatment||Drug: Irinotecan combined with cisplatin, octreotide lar||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||a Prospective Study on the Efficacy and Safety Using Sequential Therapy of Irinotecan Combined With Cisplatin (IP)and Octretide Lar in the First Line Treatment of Metastatic or Inoperable Gastrointestinal Poorly Differentiated Neuroendocrine Carcinoma: the IPO-NEC Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2013|
Experimental: Treatment arm
This 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.
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，
- Progression Free Survival for Irinotecan plus cisplatin and octreotide [ Time Frame: 2 years ]The primary objective is to investigate the overall progression free suvival for irinotecan plus cisplatin and octretide. The respective PFS of the two treatment steps will also be investigated. The result will be compared with the history treatment outcomes for patients of poorly differentiated neuroendocrine carcinoma.
- Disease control rate [ Time Frame: 2 years ]The second objective includes the disease control rate of irinotecan plus cisplatin and octretide theray.
- Overall survival [ Time Frame: 3 years ]The secondary objective includes the investigation of the overall survival for the patients receiving the sequential treatment of irinotecan plus cisplatin and octretide.
- Safety [ Time Frame: 3 years ]The secondary objective also includes the investigation on the safety profiles of the two interventions, irinotecan plus cisplatin treatment and octretide. The safety profile will be described using incidence of AEs and SAEs, using CTCAE criteria
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): NCT01480986
|Beijing Tumor Hospital|
|Beijing, Beijing, China|