Trial · NCT07901075
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
NCT07901075, Not yet recruiting, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases. Trials, record NCT07901075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
- NCT number
- NCT07901075
- Status
- Not yet recruiting
- Enrollment
- 398 participants, estimated
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic, Peritoneal Metastases, Cytoreductive Surgery
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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/NCT07901075
GET https://conductscience.org/api/trials/v1/NCT07901075/registered