NCT07471425: TOLERATE

Survival Without Persistent Limiting Toxicity: a Real Life Prospective Cohort of Advanced Neuroendocrine Tumor Followed in the French ENDOCAN-RENATEN and GTE Networks

Not yet recruiting Last updated 12 March 2026

What this trial tests

trial testing quality of life questionnaire, treatment side effect follow up in Neuroendocrine (NE) Tumors in 1,100 participants. Not yet recruiting.

Timeline

1 June 2026

Primary endpoint
1 June 2034

1 June 2034

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	1,100
Start date	1 June 2026
Primary completion	1 June 2034
Estimated completion	1 June 2034
Sites	14 locations across France

Drugs / interventions tested

• quality of life questionnaire, treatment side effect follow up

Conditions studied

• Neuroendocrine (NE) Tumors — all drugs for Neuroendocrine (NE) Tumors →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, any sex, with Neuroendocrine (NE) Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Survival without persistent limiting toxicity
  Time frame: "From enrollment to the end of follow up at 5 years"
  To determine the survival of unresectable or metastatic NET patients without limiting persistent toxicity (SPLT) in order to obtain decision support for the best therapeutic class or sequence depending on the patient and the treatments received

Sponsor's own description

Advanced neuroendocrine tumors (NETs) are rare cancers, characterized by prolonged survival (median\>5 years). If five medical options are now approved and 4 others are only recommended, the best sequence is still unknown. No single study on long-term cumulative toxicity of consecutive treatment interventions has been published so far. Taking into account real-world context is required for sound decision- making that cannot be answered by randomized trials.

Project objectives and brief description of the methods, which will be used to achieve them: Study team will construct a longitudinal prospective cohort of consecutive non resectable or metastatic NET patients using the GTE-RENATEN network to evaluate the real world cumulative and limiting toxicities. They will expect, as primary endpoint, a difference in survival without limiting (\>grade 1 adverse event according to nci.ctc V5) persistent (\>6 months) toxicity between therapeutics classes or therapeutics sequences in the real life conditions all along the treatments lines, since metastasis diagnosis. All NET primary patients will be enrolled.

Patients will be followed until the primary endpoint is reached, death or until 5 years.

Based on our pilot study, we plan to enroll 1100 patients to detect 150 events and adjust for 15 cofounders and 10% of lost to follow-up. Cox model adapted to time-related dependency will be used to analyze the data and machine learning will be utilized to take into account the number of confounding factors, interactions and nonlinear relationship. The best model of prediction will be validated in a subgroup of the cohort population.

Expected results: Study team will create a tool to help therapeutic decision in order to identify in a given patient the best therapeutic class or sequence with the lowest risk of persistent limiting toxicity.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.