NCT02409849

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

April 1, 2015

Last Update Submit

April 6, 2015

Conditions

Gastro-entero-pancreatic CarcinomaEsophageal Neuroendocrine Carcinoma

Keywords

Octreotide LARNeuroendocrine carcinomasunresectable or metastaticDisease-free survival

Outcome Measures

Primary Outcomes (1)

  • PFS

    3 years

Secondary Outcomes (1)

  • OS

    3 years

Study Arms (2)

control group

NO INTERVENTION

Octreotide LAR treatment

EXPERIMENTAL

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.

Drug: Octreotide lar

Interventions

Octreotide larDRUG
Also known as: Octreotide lar 30mg，deep i.m，q28d，
Octreotide LAR treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma.
  • High grade neuroendocrine carcinoma of esophageal or unknown primary site (if a pulmonary primary has been excluded)
  • Metastatic or unresectable disease
  • Measurable disease
  • Accepted chemotherapy with EP or IP regimen for no less than three months
  • Effectiveness with CR/PR/SD
  • Informed consent
  • Performance status of 0 or 1
  • Adequate bone marrow function (defined as absolute neutrophil count \[ANC\] \>= 1500, platelet count \[PLT\] \>= 75,000 and a hemoglobin \[Hgb\] \>= 9).
  • Adequate hepatic function with a bilirubin of \<= 2.0 mg/dl, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \<= 2.5 times the upper limits of normal, unless caused by liver metastasis. If caused by metastasis, then should be SGPT and SGOT \<= 5 times the upper limits of normal.
  • Adequate renal function defined as serum creatinine \<= 1.5 mg/dl.

You may not qualify if:

  • Patients who are on EP or IP chemotherapy for less than three months .
  • Effectiveness with PD.
  • Patients with brain metastases are not eligible.
  • Patients with New York Heart Association (NYHA) Class III or IV heart disease are not eligible as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
  • Pregnant or lactating women. All women of child bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
  • Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
  • Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
  • Patients with serum calcium \> 12 mg/dl or symptomatic hypercalcemia under treatment.
  • Patients with osseous metastasis as only site of disease.
  • Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
  • Patients with known Gilbert's syndrome are ineligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, NeuroendocrineNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lin Shen, Prof

CONTACT

+86 10 88196175lin100@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GI Oncology Department

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 7, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2018

Study Completion

June 1, 2019

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

CN(1)