Neuroendocrine (NE) TumorsETP-NETNCT07258810
Evaluation of Tolerance and Quality of Life in Patients With Neuroendocrine Tumors Treated With Oral Anti-Tumor Drugs Within a Therapeutic Education Program
An observational study of Neuroendocrine (NE) Tumors and Oral Anti-Tumor Drugs, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In recent years, the arrival of targeted oral therapies has greatly changed cancer treatment. These therapies help patients stay independent by reducing the number of hospital visits, since the treatment is given at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine (NE) Tumors, Oral Anti-Tumor Drugs, Therapeutic Education Program
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 1 Feb 2027
- 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: Recruitment will be carried out among patients hospitalized in the Medical Oncology department at Edouard Herriot University Hospital. Every consecutive patient with an indication for oral anti-tumor agents (ATO) within the context of a neuroendocrine tumor (NET) will be screened and included in the study in the absence of contraindications and after obtaining their non-opposition.
Who may be able to join
- Adult patient (>18 years) at the time of the study
- Patient diagnosed with a neuroendocrine tumor (NET) with an indication for treatment with oral anti-tumor agents (everolimus, sunitinib, cabozantinib, temozolomide +/- capecitabine, others including lenvatinib)
- Collection of the patient's non-opposition to participate in the study
Who cannot join
- Minors
- Pregnant, parturient, or breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection measures (guardianship, conservatorship)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Edouard Herriot University Hospital
Lyon, 69003
Laura Dr Gerard, +33472119167, laura.gerard@chu-lyon.fr
About this study
In recent years, the arrival of targeted oral therapies has greatly changed cancer treatment. These therapies help patients stay independent by reducing the number of hospital visits, since the treatment is given at home. However, this way of giving treatment brings specific challenges, especially in managing side effects and making sure patients follow their treatment properly.
Because of this, many patient education programs have been created to help patients learn how to manage their treatment on their own. Although only a few studies have formally looked at how useful these programs are, the available information suggests that they help patients handle side effects better and follow their treatment more closely.
Read more
Neuroendocrine tumors are a diverse group of tumors that are becoming more common. More patients with these tumors are now treated with targeted oral therapies such as everolimus, sunitinib, cabozantinib, or chemotherapy with temozolomide and capecitabine.
These treatments are often given together with a patient education program. However, so far, no study has specifically looked at how helpful these education programs are for this group of patients.
- Being tested
- Questionnaires
- Keywords
- Neuroendocrine tumor, Oral Anti-Tumor Drugs, Therapeutic Education Program, Tolerance, Quality of Life
- Medical subject headings
- Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
questionnaires given to patients in both groups: treatment adherence (MMAS-4 scale) at months 1 and 3, quality of life (EORTC QLQ-C30) at months 0, 1 and 3, and a satisfaction questionnaire developed and validated by the healthcare team and members of the French patient association for individuals with various neuroendocrine tumors (APTED) at month 3.
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled in the therapeutic education program | Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy Receives: Other: Questionnaires | |
| Patients not enrolled in the therapeutic education program | Patient with a neuroendocrine tumor requiring treatment with oral antitumor therapy Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of grade 3 to 5 adverse events in patients with neuroendocrine tumors treated with oral anti-tumor agents (ATO), based on their participation in a therapeutic education program
- Adverse effects (CTCAE v5.0) within 3 months following the initiation of ATO Grade 3-4 and 5 adverse effects: hematological, digestive, cutaneous, renal, hepatic toxicity (cytolysis >5x normal), cardiovascular (including arterial hypertension and thromboembolic complications), pulmonary (interstitial lung disease), metabolic (including hyperglycemia, lipid profile abnormalities)
- Actions taken at Month 1 and Month 3 Treatment suspension or delay of the cycle: number of suspensions, duration of suspension (in days) or number of cycle delays, duration of delay (in days) Dose reduction: reduction (yes/no), new dose Hospitalization due to adverse effects: number of hospitalizations, duration (total number of hospitalization days)
- Description of patient follow-up and therapeutic patient education program Number of consultations: teleconsultation or in-person consultation, with nurse or physician (general practitioner or oncologist) Number of phone calls: with nurse or physician
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine (NE) TumorsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Gerard, Dr, Principal investigator, Medical Oncology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258810
- Sponsor's protocol ID
- 69HCL25_0703
- Other IDs
- 2025-A01985-44
- Acronym
- ETP-NET
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerance and Quality of Life in Patients With Neuroendocrine Tumors Treated With Oral Anti-Tumor Drugs Within a Therapeutic Education Program
- ClinicalTrials.gov ID
- NCT07258810
- Acronym / sponsor ID
- ETP-NET / 69HCL25_0703
- Keywords
- Neuroendocrine tumor, Oral Anti-Tumor Drugs, Therapeutic Education Program, Tolerance, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, the arrival of targeted oral therapies has greatly changed cancer treatment. These therapies help patients stay independent by reducing the number of hospital visits, since the treatment is given at home. However, this way of giving treatment brings specific challenges, especially in managing side effects and making sure patients follow their treatment properly.
Because of this, many patient education programs have been created to help patients learn how to manage their treatment on their own. Although only a few studies have formally looked at how useful these programs are, the available information suggests that they help patients handle side effects better and follow their treatment more closely.
Neuroendocrine tumors are a diverse group of tumors that are becoming more common. More patients with these tumors are now treated with targeted oral therapies such as everolimus, sunitinib, cabozantinib, or chemotherapy with temozolomide and capecitabine.
These treatments are often given together with a patient education program. However, so far, no study has specifically looked at how helpful these education programs are for this group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled in the therapeutic education program | – | Other: QuestionnairesPatient with a neuroendocrine tumor requiring treatment with oral antitumor therapy |
| Patients not enrolled in the therapeutic education program | – | Other: QuestionnairesPatient with a neuroendocrine tumor requiring treatment with oral antitumor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be carried out among patients hospitalized in the Medical Oncology department at Edouard Herriot University Hospital. Every consecutive patient with an indication for oral anti-tumor agents (ATO) within the context of a neuroendocrine tumor (NET) will be screened and included in the study in the absence of contraindications and after obtaining their non-opposition.
Key inclusion criteria (3 listed)
- Adult patient (>18 years) at the time of the study
- Patient diagnosed with a neuroendocrine tumor (NET) with an indication for treatment with oral anti-tumor agents (everolimus, sunitinib, cabozantinib, temozolomide +/- capecitabine, others including lenvatinib)
- Collection of the patient's non-opposition to participate in the study
Key exclusion criteria (5 listed)
- Minors
- Pregnant, parturient, or breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection measures (guardianship, conservatorship)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairesquestionnaires given to patients in both groups: treatment adherence (MMAS-4 scale) at months 1 and 3, quality of life (EORTC QLQ-C30) at months 0, 1 and 3, and a satisfaction questionnaire developed and validated by the healthcare team and members of the French patient association for individuals with various neuroendocrine tumors (APTED) at month 3. | Other | Patients enrolled in the therapeutic education program, Patients not enrolled in the therapeutic education program |
Primary outcome
Assessment of the incidence of grade 3 to 5 adverse events in patients with neuroendocrine tumors treated with oral anti-tumor agents (ATO), based on their participation in a therapeutic education program
Time frame: at 3 months
* Adverse effects (CTCAE v5.0) within 3 months following the initiation of ATO Grade 3-4 and 5 adverse effects: hematological, digestive, cutaneous, renal, hepatic toxicity (cytolysis >5x normal), cardiovascular (including arterial hypertension and thromboembolic complications), pulmonary (interstitial lung disease), metabolic (including hyperglycemia, lipid profile abnormalities) * Actions taken at Month 1 and Month 3 Treatment suspension or delay of the cycle: number of suspensions, duration of suspension (in days) or number of cycle delays, duration of delay (in days) Dose reduction: reduction (yes/no), new dose Hospitalization due to adverse effects: number of hospitalizations, duration (total number of hospitalization days) * Description of patient follow-up and therapeutic patient education program Number of consultations: teleconsultation or in-person consultation, with nurse or physician (general practitioner or oncologist) Number of phone calls: with nurse or physician
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Gerard, Dr principal investigator
Medical Oncology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine (NE) Tumors and Oral Anti-Tumor Drugs, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 5 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Laura Dr Gerard (+33472119167, laura.gerard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the incidence of grade 3 to 5 adverse events in patients with neuroendocrine tumors treated with oral anti-tumor agents (ATO), based on their participation in a therapeutic education program (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.