Trial · NCT04954820
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
NCT04954820, Phase 2, Recruiting, Institut du Cancer de Montpellier - Val d'Aurelle
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET. Trials, record NCT04954820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04954820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
- NCT number
- NCT04954820
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 146 participants, estimated
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Conditions
- Neuroendocrine Tumors, Intestinal Well Differentiated Endocrine Tumor, Progressive Disease
- Interventions
- Lutathera
- First posted
- 2021-07-08
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the efficacy of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance during 6 months in patients already retreated with two cycles. | assessement every cycle (every 8 weeks) 6 months from randomization | defined as a change of tumoral assessment (Complete Response, Partial Response and Stable Disease from RECIST v1.1) with an evaluation every 2 months. |
| Secondary | Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Safety | during 6 months in patients already retreated with two cycles (each cycle is 8 weeks) | Number and type of adverse event according to NCI-CTCAE v5.0. |
| Secondary | Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Progression free survival | the time without progression of disease during 5 years after the treatment, | the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first |
| Secondary | Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Overall survival | the time without death during 5 years after the treatment | the time from randomization until death from any cause. |
| Secondary | To assess quality of life of general patient | during and after treatment in both arm : every 8 wweks during the treatment, every 3 months during 1 year post treatment and every year during 4 years post treatment | Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality-of-life questionnaire C30, no min and max values) |
| Secondary | To assess quality of life of gastrointestinal neuroendocrine tumor | during and after treatment in both arm : every 8 wweks during the treatment, every 3 months during 1 year post treatment and every year during 4 years post treatment | Quality of life will be measured by EORTC GI.NET21 questionnaire (European Organisation for Research and Treatment of Cancer, gastrointestinal neuroendocrine tumor, no min and max values) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04954820
GET https://conductscience.org/api/trials/v1/NCT04954820/registered