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Comparing 177Lu-Dotatate/Capecitabine Combination Treatment With 177Lu-Dotatate in Neuroendocrine Tumor Patients

NCT07012330 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2025-06-10

No results posted yet for this study

Summary

Peptide receptor radionuclide therapy (PRRT) with \[177Lu\]Lu-\[DOTA0,Tyr3\]octreotate (177Lu-Dotatate) is an effective and safe treatment for patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP NET). While 177Lu-Dotatate prolongs progression-free survival (PFS) and preserves quality of life (QoL), objective response rates (ORR) remain limited. Capecitabine, as radiosensitizer, could increase efficacy without increasing 177Lu-Dotatate activity. This phase II randomized controlled trial investigated the additional cytotoxic or radiosensitizing effect of capecitabine in combination with 177Lu-Dotatate.

Patients with advanced somatostatin receptor positive GEP NET or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate and capecitabine or 177Lu-Dotatate alone. Capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each PRRT cycle. Primary endpoints were ORR, PFS and median overall survival (OS). Secondary endpoints included biochemical response, adverse events and QoL.

Conditions

  • Neuroendocrine (NE) Tumors

Interventions

DRUG

Capecitabine (Xeloda)

Capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each PRRT cycle.

DRUG

177Lu-DOTATATE

Patients with advanced somatostatin receptor positive GEP NET or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-01
Primary Completion
2013-12-31
Completion
2015-12-31

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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 NCT07012330 on ClinicalTrials.gov