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Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study

NCT02358356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-07-05

No results posted yet for this study

Summary

Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).

Conditions

  • Midgut Neuroendocrine Tumours
  • Pancreatic Neuroendocrine Tumours

Interventions

DRUG

octreotate

7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV)

DRUG

Capecitabine

oral capecitabine 750mg/m2 b.i.d.

DRUG

Temozolomide

temozolomide 75mg/m2 b.i.d.

Sponsors & Collaborators

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Principal Investigators

  • Nick Pavlakis, Associate Professor · Royal North Shore Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT02358356 on ClinicalTrials.gov