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NCT Number: NCT07471425

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

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.

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Key information

Conditions

Neuroendocrine (NE) Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen, Caen, France

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About this study

Tolerate is a real life longitudinal prospective cohort of NET unresectable or metastatic patients. Patients included in this study are patients followed in ENDOCAN - RENATEN expert centres which decide for each patient therapeutic sequential strategy over time according to published ESMO and national guidelines multidisciplinary local and national boards of ENDOCAN-RENATEN network.

In addition to the follow-up performed by the ENDOCAN-RENATEN centres, the TOLERATE study will propose a remote monitoring of the adverse effects caused by cancer and treatments in patients' real life by a monthly survey (TOLERATE PRO-CTC-AE) coordinated by RESILIENCE or CUREETY which are companies approved and specialized in remote monitoring in oncology.

TOLERATE study does not affect patient's care. However, patients enrolled in this study, should not be opposed (using a non-opposition letter) to answer , in addition to the monthly survey, at baseline, every 6 months and 1 month after the administration of each new treatment, up to 5 years, quality of life questionnaires (EORTC QLQ C30, GINET-21, EQ-5D-5L, preference questionnaire and pedometer)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

quality of life questionnaire, treatment side effect follow up

Other

decrire

Primary outcomes

  1. 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

Secondary outcomes

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

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

    To evaluate the survival without persistent limiting toxicity according to nci.ctc v.5 grade 3 or 4 adverse events

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

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

    To analyze the survival without persistent, defined above 3 months, limiting toxicity according to nci.ctc v.5 grade >1 adverse events

  3. Best treatment line sequencing

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

    Best treatment line sequencing in terms of maximizing SPLT after adjustment to comorbidity, modality of follow-up and prognostic parameters

  4. Duration of each active treatment

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

    To analyze the duration of each active treatments and therapeutic breaks

  5. Best response according to local RECIST 1.1

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

    To determine best response according to local RECIST 1.1 evaluation per line

  6. Progression free survival

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

    To determine progression free survival to local RECIST 1.1 evaluation per line

  7. Time to next line systemic therapy

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

    To determine time to next line systemic therapy per line

  8. Overall survival

    Time frame: "From enrollment to the patient's death"

    To determine overall survival (whatever death cause) from the date of diagnosis of unresectable or metastatic tumor

  9. Specific survival

    Time frame: "From enrollment to the patient's death"

    To determine specific survival (death related to NET progression or toxicity due to therapeutic intervention)

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Baudin, Dr

CONTACT

[email protected]

+33142114242 ext. 33

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Acronym: TOLERATE

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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