Trial · NCT07901075
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incremental Cost-Utility Ratio (ICUR): incremental cost per quality-adjusted life-year (QALY) gained, from the French health care system perspective, at 36 months. | 36 months after the initial cytoreductive surgery | Ratio of the difference in mean total cost between the two strategies to the difference in mean number of QALYs. Costs are obtained by micro-costing of the index hospital stay and by individual linkage with the French National Health Data System (SNDS). QALYs are computed by the area-under-the-curve method from EQ-5D-5L responses collected at inclusion and at months 1, 3, 6, 12, 18, 24 and 36, valued with the French EQ-5D-5L value set. A 2.5% annual discount rate is applied. |
| Secondary | Disease-free survival (DFS) | From the initial cytoreductive surgery up to 36 months | Time from the initial cytoreductive surgery to the first recurrence or death from any cause, whichever occurs first. Recurrence is defined on clinical, biological and/or imaging criteria and validated by a multidisciplinary tumour board. Participants alive without recurrence are censored at the last evaluation. |
| Secondary | Peritoneal recurrence-free survival | From the initial cytoreductive surgery up to 36 months | Time from the initial cytoreductive surgery to the first peritoneal recurrence or death from any cause, whichever occurs first. Peritoneal recurrence is defined on clinical, biological and/or imaging criteria and validated by a multidisciplinary tumour board. Participants alive without peritoneal recurrence are censored at the last evaluation. |
| Secondary | Overall survival (OS) | From the initial cytoreductive surgery up to 36 months (minimum follow-up) | Time from the initial cytoreductive surgery to death from any cause. Participants alive are censored at the date of last contact or at the end-of-study date. |
| Secondary | Proportion of participants with at least one treatment-related toxicity | From the initial cytoreductive surgery up to 36 months | Proportion of participants presenting at least one toxicity related to oncological treatment, and the associated symptoms, graded according to NCI CTCAE version 5.0. |
| Secondary | Proportion of participants with at least one grade III-IV postoperative surgical complication | Within 90 days after the initial cytoreductive surgery | Proportion of participants presenting at least one surgical complication of Dindo-Clavien grade III or IV within 90 days after the initial cytoreductive surgery, including re-hospitalizations. |
| Secondary | Recurrence profile: metastatic sites involved | From the initial cytoreductive surgery up to 36 months | Number and proportion of participants presenting a recurrence, and description of the type of recurrence (peritoneal, hepatic, lymph node, other sites). |
| Secondary | Proportion of participants undergoing complete iterative cytoreductive surgery at recurrence | From the initial cytoreductive surgery up to 36 months | Among participants presenting a recurrence before 36 months after the initial cytoreductive surgery, proportion considered resectable and operable and actually undergoing a complete iterative cytoreductive surgery. |
| Secondary | Mean cost of the index hospital stay (micro-costing) | Index hospital stay, from admission for the initial cytoreductive surgery to hospital discharge | Mean production cost of the index hospital stay for cytoreductive surgery with or without HIPEC, from the health care provider perspective, obtained by micro-costing: identification, measurement and valuation of the resources consumed |
| Secondary | Mean total cost of care per group | From diagnosis up to 36 months after the initial cytoreductive surgery | Mean cost of care per participant in each group, from the French health care system perspective, calculated from SNDS data (all reimbursed care from diagnosis, including systemic treatments) combined with the micro-costing of the index stay. |
| Secondary | Budget impact for the French statutory health insurance | 5 years | Net benefit (additional costs or savings) for the French statutory health insurance attributable to an increase in the number of HIPEC procedures performed in this indication, comparing the current situation with an alternative scenario of progressive development of CRS plus HIPEC. |
| Secondary | Incremental cost-effectiveness ratio (ICER) at 3 and 5 years | 3 years and 5 years after the initial cytoreductive surgery | ICER expressed as incremental cost per life-year gained, from the French health care system perspective. Effectiveness data (3-year and 5-year mortality) are obtained from the electronic case report form and from the SNDS databases. |
| Secondary | Health-related quality of life measured by the EORTC QLQ-C30 | Inclusion (preoperative consultation), then months 1, 3, 6, 12, 18, 24 and 36 after the initial cytoreductive surgery | Mean scores of the EORTC QLQ-C30 cancer-specific self-administered questionnaire (global health status, functional scales and symptom scales, each transformed to a 0-100 scale). |
| Secondary | Patient-reported outcomes measured by the PERI-PROM questionnaire | Inclusion (preoperative consultation), then months 1, 3, 6, 12, 18, 24 and 36 after the initial cytoreductive surgery | Mean scores of the PERI-PROM questionnaire, the core set of patient-reported outcome measures developed for peritoneal surface malignancies. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07901075/registered