Trial · NCT07910760
TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
NCT07910760, Phase 3, Not yet recruiting, Tata Memorial Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS. Trials, record NCT07910760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910760
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
- NCT number
- NCT07910760
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 123 participants, estimated
- Lead sponsor
- Tata Memorial Hospital
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumors
- Interventions
- Capecitabine, Temozolomide (TMZ), Lutetium Lu 177 Dotatate
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-Year Progression-Free Survival (PFS) | 1 year after randomization | Proportion of patients who remain free from disease progression at 1 year following randomization, comparing PRRT plus CAPTEM versus CAPTEM alone in patients with well-differentiated Grade 3 gastroenteropancreatic neuroendocrine tumors. Disease progression will be assessed using RECIST 1.1 criteria. |
| Secondary | Disease Control Rate (DCR) | 1 year after randomization | Percentage of patients achieving complete response, partial response, or stable disease according to RECIST 1.1 criteria in the two treatment arms. |
| Secondary | Overall Survival (OS) | From randomization until death or end of study follow-up (up to 5 years) | Comparison of overall survival between patients receiving PRRT plus CAPTEM and those receiving CAPTEM alone. Overall survival is defined as the time from randomization to death from any cause. |
| Secondary | Incidence of Grade 3 or Higher Treatment-Related Toxicities | Throughout treatment and up to 30 days after completion/discontinuation of protocol treatment | Comparison of the incidence and severity of treatment-related adverse events between the two study arms, with particular focus on Grade 3 or higher toxicities as assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE). |
| Secondary | Change from baseline in global health status/quality of life, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Baseline up to 12 months (Arm A: every 4-6 months; Arm B: before each PRRT session; both arms: at scheduled follow-up visits) | The EORTC QLQ-C30 (version 3.0) is a 30-item cancer-specific quality-of-life questionnaire. It has a global health status/quality of life scale, five functional scales, three symptom scales and six single items. Raw scores are linearly transformed to a 0-100 scale (minimum 0, maximum 100). For the global health status/quality of life scale and the functional scales, higher scores mean better quality of life and functioning (a better outcome). For the symptom scales and single items, higher scores mean more severe symptoms (a worse outcome). The change from baseline in the global health status/quality of life score will be compared between the two arms. |
| Secondary | Change from baseline in symptom scores, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Neuroendocrine Tumour module (EORTC QLQ-GI.NET21) | Baseline up to 12 months (Arm A: every 4-6 months; Arm B: before each PRRT session; both arms: at scheduled follow-up visits) | he EORTC QLQ-GI.NET21 is a 21-item questionnaire for patients with gastrointestinal neuroendocrine tumours. It has five multi-item scales (endocrine symptoms, gastrointestinal symptoms, treatment-related symptoms, social function and disease-related worries) and single items, including muscle/bone pain and body image. Each item is answered on a 4-point scale, and scores are linearly transformed to a 0-100 scale (minimum 0, maximum 100). Higher scores mean more severe symptoms or problems (a worse outcome). The change from baseline in each scale score will be compared between the two arms. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07910760
GET https://conductscience.org/api/trials/v1/NCT07910760/registered