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Neuroendocrine (NE) TumorsTOLERATENCT07471425

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

An observational study of Neuroendocrine (NE) Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 14 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine (NE) Tumors
What is being tested?
quality of life questionnaire, treatment side effect follow up
How many people
1,100 participants
Where
14 sitesFrance
Study dates
Jun 2026to Jun 2034
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: unresectable or metastatic NET patients

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Baudin, Dr contact

+33142114242 ext. 33

eric.baudin@gustaveroussy.fr

14 sites in 1 country

France14 sites

  • CHU Caen

    Caen, 14000

    Karine BOUHIER LEPORRIER, Dr, +33231065262, bouhierleporrier-k@chu-caen.fr

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

    Igor Tauveron, Pr, +33473751433, itauveron@chu-clermontferrand.fr

  • APHP Beaujon

    Clichy, 92110

    Olivia Hentic, Dr, +33140875225, olivia.hentic@aphp.fr

  • CHU Dijon

    Dijon, 21000

    Come Lepage, Pr, +33380293750, come.lepage@u-bourgogne.fr

  • CHU Lille

    Lille, 59000

    Christine Do Cao, Dr, +33320444518, Christine.DOCAO@chu-lille.fr

  • Hôpital Edouard Herriot

    Lyon, 69003

    Laura Gerard, Dr, +33472110094, laura.gerard@chu-lyon.fr

  • APHM Marseille La Timone

    Marseille, 13005

    Laetitia Dahan, Pr, +33491388205, Laetitia.DAHAN@ap-hm.fr

  • APHP Cochin

    Paris, 75014

    Romain Coriat, Pr, +33158414243, Romain.coriat@aphp.fr

  • CHU Poitiers

    Poitiers, 86196

    Aurélie Ferru, Dr, +33549444321, aurelie.ferru@chu-poitiers.fr

  • CHU Reims

    Reims, 51092

    Marine Perrier, Dr, +33388127600, mperrier@chu-reims.fr

  • Centre Eugene Maquis

    Rennes, 35000

    Marc Practh, Dr, +33299253196, m.pracht@rennes.unicancer.fr

  • CHU Strasbourg

    Strasbourg, 67200

    Philippe BALTZINGER, Dr, +33388127600, philippe.baltzinger@chru-strasbourg.fr

  • CHU Toulouse

    Toulouse, 31300

    Rosine Guimbaud, Pr, +330561322142, guimbaud.r@chu-toulouse.fr

  • CHRU Tours

    Tours, 37044

    Thierry Lecomte, Pr, +33247479171, thierry.lecomte@univ-tours.fr

Other trials in France

About this study

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

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.

Read more

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.

Read the detailed description

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)

Being tested
quality of life questionnaire, treatment side effect follow up
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality of life questionnaire, treatment side effect follow upOther

    decrire

Study groups in NCT07471425
Study groupRoleWhat they receive
TOLERATE cohortadvanced neuroendocrine cancers followed in the French ENDOCAN - RENATEN and GTE networks
Receives: Other: quality of life questionnaire, treatment side effect follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)

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

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

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

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

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

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

  3. Best treatment line sequencing

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

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

  4. Duration of each active treatment

    To analyze the duration of each active treatments and therapeutic breaks

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

  5. Best response according to local RECIST 1.1

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

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

  6. Progression free survival

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

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

  7. Time to next line systemic therapy

    To determine time to next line systemic therapy per line

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

  8. Overall survival

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

    Measured: "From enrollment to the patient's death"

  9. Specific survival

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

    Measured: "From enrollment to the patient's death"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2034 (estimated)
  4. Study completionJun 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,100 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07471425
Sponsor's protocol ID
2024-A02354-43
Other IDs
CSET number 2023/3770
Acronym
TOLERATE
Status last verified
Mar 2026
First submitted
5 Mar 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Watson C, Tallentire CW, Ramage JK, Srirajaskanthan R, Leeuwenkamp OR, Fountain D. Quality of life in patients with gastroenteropancreatic tumours: A systematic literature review. World J Gastroenterol. 2020 Jul 7;26(25):3686-3711. doi: 10.3748/wjg.v26.i25.3686.

    PubMed 32742136

  • Pearman TP, Beaumont JL, Cella D, Neary MP, Yao J. Health-related quality of life in patients with neuroendocrine tumors: an investigation of treatment type, disease status, and symptom burden. Support Care Cancer. 2016 Sep;24(9):3695-703. doi: 10.1007/s00520-016-3189-z. Epub 2016 Mar 31.

    PubMed 27029477

  • Yadegarfar G, Friend L, Jones L, Plum LM, Ardill J, Taal B, Larsson G, Jeziorski K, Kwekkeboom D, Ramage JK; EORTC Quality of Life Group. Validation of the EORTC QLQ-GINET21 questionnaire for assessing quality of life of patients with gastrointestinal neuroendocrine tumours. Br J Cancer. 2013 Feb 5;108(2):301-10. doi: 10.1038/bjc.2012.560. Epub 2013 Jan 15.

    PubMed 23322194

  • Berdelou A, Boige V, Arfi-Rouche J, Malka D, Ederhy S, Izzedine H, Leboulleux S, Chougnet CN, Burtin P, De Baere T, Laplanche A, Elias D, Schlumberger M, Scoazec JY, Ducreux M, Baudin E. Not All Patients with a Pancreatic Neuroendocrine Tumour Will Benefit from All Approved or Recommended Therapeutic Options: A Real-Life Retrospective Study. Neuroendocrinology. 2017;105(1):26-34. doi: 10.1159/000446988. Epub 2016 May 26.

    PubMed 27225439

  • Strauss SJ, Frezza AM, Abecassis N, Bajpai J, Bauer S, Biagini R, Bielack S, Blay JY, Bolle S, Bonvalot S, Boukovinas I, Bovee JVMG, Boye K, Brennan B, Brodowicz T, Buonadonna A, de Alava E, Dei Tos AP, Garcia Del Muro X, Dufresne A, Eriksson M, Fagioli F, Fedenko A, Ferraresi V, Ferrari A, Gaspar N, Gasperoni S, Gelderblom H, Gouin F, Grignani G, Gronchi A, Haas R, Hassan AB, Hecker-Nolting S, Hindi N, Hohenberger P, Joensuu H, Jones RL, Jungels C, Jutte P, Kager L, Kasper B, Kawai A, Kopeckova K, Krakorova DA, Le Cesne A, Le Grange F, Legius E, Leithner A, Lopez Pousa A, Martin-Broto J, Merimsky O, Messiou C, Miah AB, Mir O, Montemurro M, Morland B, Morosi C, Palmerini E, Pantaleo MA, Piana R, Piperno-Neumann S, Reichardt P, Rutkowski P, Safwat AA, Sangalli C, Sbaraglia M, Scheipl S, Schoffski P, Sleijfer S, Strauss D, Sundby Hall K, Trama A, Unk M, van de Sande MAJ, van der Graaf WTA, van Houdt WJ, Frebourg T, Ladenstein R, Casali PG, Stacchiotti S; ESMO Guidelines Committee, EURACAN, GENTURIS and ERN PaedCan. Electronic address: clinicalguidelines@esmo.org. Bone sarcomas: ESMO-EURACAN-GENTURIS-ERN PaedCan Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2021 Dec;32(12):1520-1536. doi: 10.1016/j.annonc.2021.08.1995. Epub 2021 Sep 6. No abstract available.

    PubMed 34500044

  • Singh S, Granberg D, Wolin E, Warner R, Sissons M, Kolarova T, Goldstein G, Pavel M, Oberg K, Leyden J. Patient-Reported Burden of a Neuroendocrine Tumor (NET) Diagnosis: Results From the First Global Survey of Patients With NETs. J Glob Oncol. 2016 Jun 8;3(1):43-53. doi: 10.1200/JGO.2015.002980. eCollection 2017 Feb.

    PubMed 28717741

  • Plante A, Baudin E, Do Cao C, Hentic O, Dubreuil O, Terrebonne E, Granger V, Smith D, Lombard-Bohas C, Walter T. Patient-reported tolerance in treatments approved in neuroendocrine tumors: A national survey from the French Group of Endocrine Tumors. Clin Res Hepatol Gastroenterol. 2018 Apr;42(2):153-159. doi: 10.1016/j.clinre.2017.10.003. Epub 2017 Nov 20.

    PubMed 29158141

  • Moertel CG, Lefkopoulo M, Lipsitz S, Hahn RG, Klaassen D. Streptozocin-doxorubicin, streptozocin-fluorouracil or chlorozotocin in the treatment of advanced islet-cell carcinoma. N Engl J Med. 1992 Feb 20;326(8):519-23. doi: 10.1056/NEJM199202203260804.

    PubMed 1310159

  • Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

    PubMed 28076709

  • Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825.

    PubMed 21306237

  • Rinke A, Neary MP, Eriksson J, Hunger M, Doan T, Karli D, Arnold R. Health-Related Quality of Life for Long-Acting Octreotide versus Placebo in Patients with Metastatic Midgut Neuroendocrine Tumors in the Phase 3 PROMID Trial. Neuroendocrinology. 2019;109(2):141-151. doi: 10.1159/000499469. Epub 2019 Mar 11.

    PubMed 30852564

  • Yao JC, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, Tomasek J, Raderer M, Lahner H, Voi M, Pacaud LB, Rouyrre N, Sachs C, Valle JW, Fave GD, Van Cutsem E, Tesselaar M, Shimada Y, Oh DY, Strosberg J, Kulke MH, Pavel ME; RAD001 in Advanced Neuroendocrine Tumours, Fourth Trial (RADIANT-4) Study Group. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016 Mar 5;387(10022):968-977. doi: 10.1016/S0140-6736(15)00817-X. Epub 2015 Dec 17.

    PubMed 26703889

  • Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193.

    PubMed 28444114

  • Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Oberg K. Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. doi: 10.1200/JCO.2016.68.0702. Epub 2016 Sep 30.

    PubMed 27621394

  • Baudin E, Caplin M, Garcia-Carbonero R, Fazio N, Ferolla P, Filosso PL, Frilling A, de Herder WW, Horsch D, Knigge U, Korse CM, Lim E, Lombard-Bohas C, Pavel M, Scoazec JY, Sundin A, Berruti A; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Lung and thymic carcinoids: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021 Apr;32(4):439-451. doi: 10.1016/j.annonc.2021.01.003. Epub 2021 Jan 19. No abstract available.

    PubMed 33482246

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroendocrine (NE) Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Baudin, Dr (+33142114242 ext. 33, eric.baudin@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival without persistent limiting toxicity (time frame: "From enrollment to the end of follow up at 5 years"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07471425, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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