Survival Without Persistent Limiting Toxicity: Real Life Prospective Cohort of Advanced Neuroendocrine Tumor

NCT07471425 | Not Yet Recruiting

• 2 other identifiers: 2024-A02354-43CSET number 2023/3770
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Neuroendocrine (NE) Tumors

Outcome Measures

Primary Outcomes (1)

• Survival without persistent limiting toxicity

  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

  "From enrollment to the end of follow up at 5 years"

Secondary Outcomes (9)

• Survival without persistent limiting toxicity according to nci.ctc v.5 grade 3 or 4 adverse events

  "From enrollment to the end of follow up at 5 years"

• Survival without persistent, defined above 3 months, limiting toxicity according to nci.ctc v.5 grade >1 adverse events

  "From enrollment to the end of follow up at 5 years"

• Best treatment line sequencing

  "From enrollment to the end of follow up at 5 years"

• Duration of each active treatment

  "From enrollment to the end of follow up at 5 years"

• Best response according to local RECIST 1.1

  "From enrollment to the end of follow up at 5 years"

Study Arms (1)

TOLERATE cohort

advanced neuroendocrine cancers followed in the French ENDOCAN - RENATEN and GTE networks

Other: quality of life questionnaire, treatment side effect follow up

Interventions

quality of life questionnaire, treatment side effect follow up OTHER

decrire

TOLERATE cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

unresectable or metastatic NET patients

You may qualify if:

• Unresectable local or metastatic NET naive of treatment tumor except somatostatin analogues or primary surgery.
• Unresectable local or metastatic NET newly diagnosed\<6 months whatever the primary NET site
• Well differentiated neuroendocrine tumor (WHO classifications) pathologically reviewed locally
• No initial medical absolute contraindication to any of the authorized or recommended treatments (no AE\>grade 1 according to NCI CTC v.5 criteria),
• Patient who have full medical follow-up in an expert center of the French ENDOCAN network for the management of their advanced neuroendocrine tumor
• Patient not opposed to data collection in the on GTE databasis
• Patient not opposed to participate in the clinical study

You may not qualify if:

• Patients with severe illness that contraindicates participation to any study
• Age \<18 years old

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (14)

CHU Caen

Caen, 14000, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

APHP Beaujon

Clichy, 92110, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU Lille

Lille, 59000, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

APHM Marseille La Timone

Marseille, 13005, France

Location

APHP Cochin

Paris, 75014, France

Location

CHU Poitiers

Poitiers, 86196, France

Location

CHU Reims

Reims, 51092, France

Location

Centre Eugene Maquis

Rennes, 35000, France

Location

CHU Strasbourg

Strasbourg, 67200, France

Location

CHU Toulouse

Toulouse, 31300, France

Location

CHRU Tours

Tours, 37044, France

Location

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MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Eric Baudin, Dr

CONTACT

+33142114242; eric.baudin@gustaveroussy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (14)