Hyperthermic Intraperitoneal ChemotherapECO-CHIPNCT07901075
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
An observational study of Hyperthermic Intraperitoneal Chemotherap and Colorectal Cancer Metastatic, run by Hospices Civils de Lyon.
Trial summary
Colorectal cancer is the second leading cause of cancer death in France, with close to 50,000 new cases each year. About half of the patients develop liver, lung and/or peritoneal metastases during the course of the disease.Peritoneal involvement, which accounts for approximately 8,000 new cases per year, carries the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic, Peritoneal Metastases
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2027to 12 Dec 2032
- 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: Adult patients with histologically confirmed colorectal cancer and resectable peritoneal metastases, managed surgically in French expert centers for peritoneal surface malignancies.
Who may be able to join
- Male or female aged 18 years or older.
- Colorectal cancer with histologically confirmed synchronous or metachronous peritoneal metastases.
- Peritoneal Cancer Index (PCI) between 5 and 20 inclusive at cytoreductive surgery.
- Five or fewer associated liver metastases.
- Indication for complete cytoreductive surgery (CC-0/1), with or without HIPEC according to the routine practice of the center.
- Maximum of 6 cycles of preoperative neoadjuvant chemotherapy
- Patient information and non-opposition to data use.
Who cannot join
- Active cancer of non-colorectal origin, in particular appendiceal.
- Colorectal adenocarcinoma with signet-ring cells.
- Person deprived of liberty by a judicial or administrative decision.
- Adult under a legal protection measure.
- Criteria for premature withdrawal, assessed intraoperatively at surgical exploration: PCI < 5 or PCI > 20; completeness of cytoreduction (CC) score > 1; more than 5 liver metastases.
About this study
Official title: ECO-CHIP: Cost-utility Evaluation of Cytoreductive Surgery Combined With Mitomycin-C Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Versus Cytoreductive Surgery Alone in the Treatment of Resectable Colorectal Peritoneal Metastases. A National, Multicenter, Prospective, Comparative, Non-randomized, Non-interventional Study.
Colorectal cancer is the second leading cause of cancer death in France, with close to 50,000 new cases each year. About half of the patients develop liver, lung and/or peritoneal metastases during the course of the disease.Peritoneal involvement, which accounts for approximately 8,000 new cases per year, carries the poorest prognosis, notably because of its chemoresistance.For patients with resectable colorectal peritoneal metastases,recommended optimal management combines systemic chemotherapy with complete cytoreductive surgery(CRS)in an expert center.Hyperthermic IntraPeritoneal Chemotherapy(HIPEC)may be added to CRS to eradicate residual microscopic disease and potentially improve survival.Clinical evidence on HIPEC for colorectal peritoneal carcinomatosis is heterogeneous and dominated by a randomized trial reporting no survival benefit and increased morbidity, results attributed to the oxaliplatin-based HIPEC regimen used. A separate body of evidence suggests a benefit of mitomycin-C-based HIPEC, with manageable morbidity and preserved quality of life. National and international guidelines therefore allow mitomycin-C HIPEC, but the procedure remains controversial: according to French hospital discharge data, about half of the patients treated for colorectal peritoneal carcinomatosis receive CRS plus HIPEC and the other half CRS alone.HIPEC also raises funding and efficiency issues. No specific French diagnosis-related tariff (GHS)exists for CRS plus HIPEC, whereas the procedure is costly in terms of operating time,human and material resources, and is associated with prolonged hospital stays and complications. To date, no prospective comparative data on the efficiency of CRS plus HIPEC are available in France.ECO-CHIP is a national,multicenter, prospective, comparative,non-randomized, open, non-interventional study using a " here-elsewhere " design (French RIPH category 3). Each participating center follows its own routine practice: centers performing HIPEC treat included patients with CRS plus mitomycin-C HIPEC (innovative strategy), while centers not performing HIPEC treat included patients with CRS alone (reference strategy).No change in management, examination or procedure is imposed by the protocol.the only procedure added because of the research is the completion of self-administered questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29 and PERI-PROM) at inclusion and at months 1, 3, 6, 12, 18, 24 and 36 after cytoreductive surgery. The primary objective is to assess, from the French health care system perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System(SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity, postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life.
Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival (expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone, hazard ratio 0.66) and quality-adjusted survival at an acceptable incremental cost per QALY gained.
Read more
perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System (SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity,postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life.
Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival(expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone,hazard ratio 0.66)and quality-adjusted survival at an acceptable incremental cost per QALY gained.A total of 398 patients 199per group are planned for inclusion in French digestive and surgical oncology departments over a 36-month enrolment period, each patient being followed for 36 months
- Conditions
- Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic, Peritoneal Metastases, Cytoreductive Surgery
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRS plus mitomycin-C HIPEC. | Intervention: Cytoreductive Surgery (CRS) plus mitomycin-C HIPEC. Complete cytoreductive surgery (CC-0/1) according to the center's usual standards, followed by intraperitoneal mitomycin C 35 mg/m2 fractionated in 3 doses (50% at T0, 25% at T30, 25% at T60) for 90 minutes at 41-43°C, as a single intraoperative procedure. Intervention: Patient-reported outcome questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29, PERI-PROM), completed at inclusion and at months 1, 3, 6, 12, 18, 24 and 36. All other care and follow-up visits are performed as part of routine practice. | |
| CRS alone | Intervention: Cytoreductive Surgery (CRS) alone. Complete cytoreductive surgery (CC-0/1) according to the center's usual standards, without HIPEC. Intervention: Patient-reported outcome questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29, PERI-PROM), completed at inclusion and at months 1, 3, 6, 12, 18, 24 and 36. All other care and follow-up visits are performed as part of routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-Utility Ratio (ICUR): incremental cost per quality-adjusted life-year (QALY) gained, from the French health care system perspective, at 36 months.
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.
Measured: 36 months after the initial cytoreductive surgery
Secondary outcomes (13)
Disease-free survival (DFS)
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.
Measured: From the initial cytoreductive surgery up to 36 months
Peritoneal recurrence-free survival
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.
Measured: From the initial cytoreductive surgery up to 36 months
Overall survival (OS)
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.
Measured: From the initial cytoreductive surgery up to 36 months (minimum follow-up)
Proportion of participants with at least one treatment-related toxicity
Proportion of participants presenting at least one toxicity related to oncological treatment, and the associated symptoms, graded according to NCI CTCAE version 5.0.
Measured: From the initial cytoreductive surgery up to 36 months
Proportion of participants with at least one grade III-IV postoperative surgical complication
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.
Measured: Within 90 days after the initial cytoreductive surgery
Recurrence profile: metastatic sites involved
Number and proportion of participants presenting a recurrence, and description of the type of recurrence (peritoneal, hepatic, lymph node, other sites).
Measured: From the initial cytoreductive surgery up to 36 months
Proportion of participants undergoing complete iterative cytoreductive surgery at recurrence
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.
Measured: From the initial cytoreductive surgery up to 36 months
Mean cost of the index hospital stay (micro-costing)
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
Measured: Index hospital stay, from admission for the initial cytoreductive surgery to hospital discharge
Mean total cost of care per group
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.
Measured: From diagnosis up to 36 months after the initial cytoreductive surgery
Budget impact for the French statutory health insurance
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.
Measured: 5 years
Incremental cost-effectiveness ratio (ICER) at 3 and 5 years
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.
Measured: 3 years and 5 years after the initial cytoreductive surgery
Health-related quality of life measured by the EORTC QLQ-C30
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).
Measured: Inclusion (preoperative consultation), then months 1, 3, 6, 12, 18, 24 and 36 after the initial cytoreductive surgery
Patient-reported outcomes measured by the PERI-PROM questionnaire
Mean scores of the PERI-PROM questionnaire, the core set of patient-reported outcome measures developed for peritoneal surface malignancies.
Measured: Inclusion (preoperative consultation), then months 1, 3, 6, 12, 18, 24 and 36 after the initial cytoreductive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start12 Jan 2027 (estimated)
- Primary completion12 Dec 2029 (estimated)
- Study completion12 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperthermic Intraperitoneal ChemotherapStudies 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
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901075
- Sponsor's protocol ID
- 69HCL25_0884
- Acronym
- ECO-CHIP
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECO-CHIP: Cost-utility Evaluation of Cytoreductive Surgery Combined With Mitomycin-C Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Versus Cytoreductive Surgery Alone in the Treatment of Resectable Colorectal Peritoneal Metastases. A National, Multicenter, Prospective, Comparative, Non-randomized, Non-interventional Study.
- ClinicalTrials.gov ID
- NCT07901075
- Acronym / sponsor ID
- ECO-CHIP / 69HCL25_0884
- Conditions
- Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic, Peritoneal Metastases, Cytoreductive Surgery
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Jan 2027 (estimated)
- Primary completion
- 12 Dec 2029 (estimated)
- Study completion
- 12 Dec 2032 (estimated)
- First posted
- 28 Oct 2026 (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.
Colorectal cancer is the second leading cause of cancer death in France, with close to 50,000 new cases each year. About half of the patients develop liver, lung and/or peritoneal metastases during the course of the disease.Peritoneal involvement, which accounts for approximately 8,000 new cases per year, carries the poorest prognosis, notably because of its chemoresistance.For patients with resectable colorectal peritoneal metastases,recommended optimal management combines systemic chemotherapy with complete cytoreductive surgery(CRS)in an expert center.Hyperthermic IntraPeritoneal Chemotherapy(HIPEC)may be added to CRS to eradicate residual microscopic disease and potentially improve survival.Clinical evidence on HIPEC for colorectal peritoneal carcinomatosis is heterogeneous and dominated by a randomized trial reporting no survival benefit and increased morbidity, results attributed to the oxaliplatin-based HIPEC regimen used. A separate body of evidence suggests a benefit of mitomycin-C-based HIPEC, with manageable morbidity and preserved quality of life. National and international guidelines therefore allow mitomycin-C HIPEC, but the procedure remains controversial: according to French hospital discharge data, about half of the patients treated for colorectal peritoneal carcinomatosis receive CRS plus HIPEC and the other half CRS alone.HIPEC also raises funding and efficiency issues. No specific French diagnosis-related tariff (GHS)exists for CRS plus HIPEC, whereas the procedure is costly in terms of operating time,human and material resources, and is associated with prolonged hospital stays and complications. To date, no prospective comparative data on the efficiency of CRS plus HIPEC are available in France.ECO-CHIP is a national,multicenter, prospective, comparative,non-randomized, open, non-interventional study using a " here-elsewhere " design (French RIPH category 3). Each participating center follows its own routine practice: centers performing HIPEC treat included patients with CRS plus mitomycin-C HIPEC (innovative strategy), while centers not performing HIPEC treat included patients with CRS alone (reference strategy).No change in management, examination or procedure is imposed by the protocol.the only procedure added because of the research is the completion of self-administered questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29 and PERI-PROM) at inclusion and at months 1, 3, 6, 12, 18, 24 and 36 after cytoreductive surgery. The primary objective is to assess, from the French health care system perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System(SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity, postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life.
Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival (expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone, hazard ratio 0.66) and quality-adjusted survival at an acceptable incremental cost per QALY gained.
perspective and over a 36-month horizon, the efficiency (cost-utility) of cytoreductive surgery combined with mitomycin-C HIPEC versus cytoreductive surgery alone. Costs are derived from micro-costing of the index hospital stay and from individual linkage with the French National Health Data System (SNDS); utilities are derived from the EQ-5D-5L using the French value set. Secondary objectives compare the two strategies in terms of disease-free survival, peritoneal recurrence-free survival, overall survival, toxicity,postoperative complications, recurrence patterns, access to iterative complete cytoreduction, costs, budget impact for the French statutory health insurance, cost-effectiveness at 3 and 5 years, and health-related quality of life.
Study hypothesis: the addition of mitomycin-C HIPEC to complete cytoreductive surgery is an efficient strategy for the French health care system, improving disease-free survival(expected 3-year disease-free survival of 26% with CRS plus HIPEC versus 13% with CRS alone,hazard ratio 0.66)and quality-adjusted survival at an acceptable incremental cost per QALY gained.A total of 398 patients 199per group are planned for inclusion in French digestive and surgical oncology departments over a 36-month enrolment period, each patient being followed for 36 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRS plus mitomycin-C HIPEC. | – | –Intervention: Cytoreductive Surgery (CRS) plus mitomycin-C HIPEC. Complete cytoreductive surgery (CC-0/1) according to the center's usual standards, followed by intraperitoneal mitomycin C 35 mg/m2 fractionated in 3 doses (50% at T0, 25% at T30, 25% at T60) for 90 minutes at 41-43°C, as a single intraoperative procedure. Intervention: Patient-reported outcome questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29, PERI-PROM), completed at inclusion and at months 1, 3, 6, 12, 18, 24 and 36. All other care and follow-up visits are performed as part of routine practice. |
| CRS alone | – | –Intervention: Cytoreductive Surgery (CRS) alone. Complete cytoreductive surgery (CC-0/1) according to the center's usual standards, without HIPEC. Intervention: Patient-reported outcome questionnaires (EQ-5D-5L, EORTC QLQ-C30, EORTC QLQ-CR29, PERI-PROM), completed at inclusion and at months 1, 3, 6, 12, 18, 24 and 36. All other care and follow-up visits are performed as part of routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed colorectal cancer and resectable peritoneal metastases, managed surgically in French expert centers for peritoneal surface malignancies.
Key inclusion criteria (7 listed)
- Male or female aged 18 years or older.
- Colorectal cancer with histologically confirmed synchronous or metachronous peritoneal metastases.
- Peritoneal Cancer Index (PCI) between 5 and 20 inclusive at cytoreductive surgery.
- Five or fewer associated liver metastases.
- Indication for complete cytoreductive surgery (CC-0/1), with or without HIPEC according to the routine practice of the center.
Key exclusion criteria (5 listed)
- Active cancer of non-colorectal origin, in particular appendiceal.
- Colorectal adenocarcinoma with signet-ring cells.
- Person deprived of liberty by a judicial or administrative decision.
- Adult under a legal protection measure.
- Criteria for premature withdrawal, assessed intraoperatively at surgical exploration: PCI < 5 or PCI > 20; completeness of cytoreduction (CC) score > 1; more than 5 liver metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incremental Cost-Utility Ratio (ICUR): incremental cost per quality-adjusted life-year (QALY) gained, from the French health care system perspective, at 36 months.
Time frame: 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.
13 secondary outcomes
Disease-free survival (DFS)
Time frame: From the initial cytoreductive surgery up to 36 months
Peritoneal recurrence-free survival
Time frame: From the initial cytoreductive surgery up to 36 months
Overall survival (OS)
Time frame: From the initial cytoreductive surgery up to 36 months (minimum follow-up)
Proportion of participants with at least one treatment-related toxicity
Time frame: From the initial cytoreductive surgery up to 36 months
Proportion of participants with at least one grade III-IV postoperative surgical complication
Time frame: Within 90 days after the initial cytoreductive surgery
Recurrence profile: metastatic sites involved
Time frame: From the initial cytoreductive surgery up to 36 months
Proportion of participants undergoing complete iterative cytoreductive surgery at recurrence
Time frame: From the initial cytoreductive surgery up to 36 months
Mean cost of the index hospital stay (micro-costing)
Time frame: Index hospital stay, from admission for the initial cytoreductive surgery to hospital discharge
Mean total cost of care per group
Time frame: From diagnosis up to 36 months after the initial cytoreductive surgery
Budget impact for the French statutory health insurance
Time frame: 5 years
Incremental cost-effectiveness ratio (ICER) at 3 and 5 years
Time frame: 3 years and 5 years after the initial cytoreductive surgery
Health-related quality of life measured by the EORTC QLQ-C30
Time frame: Inclusion (preoperative consultation), then months 1, 3, 6, 12, 18, 24 and 36 after the initial cytoreductive surgery
Patient-reported outcomes measured by the PERI-PROM questionnaire
Time frame: Inclusion (preoperative consultation), then months 1, 3, 6, 12, 18, 24 and 36 after the initial cytoreductive surgery
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 28 Oct 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthermic Intraperitoneal Chemotherap and Colorectal Cancer Metastatic, run by Hospices Civils de Lyon.
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 7 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost-Utility Ratio (ICUR): incremental cost per quality-adjusted life-year (QALY) gained, from the French health care system perspective, at 36 months. (time frame: 36 months after the initial cytoreductive surgery). 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 28 Oct 2026.