NCT02409849

Octreotide LAR as Maintenance Treatment for Patients With NEC

Randomized Phase II Study of Octreotide LAR as Maintenance Treatment After First-line Chemotherapy for Patients With Unresectable or Metastatic Gastro-entero-pancreatic or Esophageal Neuroendocrine Carcinomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is phase II study on the efficacy of octreotide lar as maintenance treatment after first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic or esophageal neuroendocrine carcinomas.

Detailed description

This is a prospective, randomized, open label study on the efficacy of octreotide lar as maintenance treatment after first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic or esophageal neuroendocrine carcinomas.The patients with unresectable or metastatic GEP or esophageal NEC who got CR/PR/SD after chemotherapy with IP or EP regimen qualified with the inclusion criteria are enrolled. All the patients enrolled in our study will be randomly assigned to receive octreotide LAR (group A) as maintenance treatment or follow up (group B) to disease progression. Treatment will be discontinued on withdrawal of patient consent, disease progression, unacceptable toxicity, a treatment delay of \>2 weeks, or major protocol violations, after which patients were followed up every 3 months for a minimum of 12 months.

Conditions

• Gastro-entero-pancreatic Carcinoma
• Esophageal Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Octreotide lar

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-11-01
• Completion: 2019-06-01
• First posted: 2015-04-07
• Last updated: 2015-04-07

Locations

1 site across 1 country: China