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CHIPOR : Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517390-24-00
Acronym
UC-0120/1004
Enrollment
383
Registered
2024-09-25
Start date
2011-04-26
Completion date
Unknown
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian epithelial cancer : intraperitoneal resectable relapse

Brief summary

The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.

Detailed description

Relapse-free Survival : Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytological diagnostic), biological criteria (confirmed elevation of CA 125 markers according to RUSTIN criteria) or medical imaging criteria (detection of measurable mass, with the new RECIST criteria). The main criteria will be the date at which relapse occurrence is detected., Pain and Quality of Life : Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer). Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis., Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale, Morbidity : Morbidity evaluation will be performed until the 60th day after surgery, taking into account: - deaths - severe complications, Medico-economic study: collection of socio-demographical data and patient management costs., Pharmacokinetic study: on 50 patients included who received HIPEC (25 in the open method and 25 in the closed method: Analysis of platinum concentrations at the peritoneal, plasma and tissue levels.

Interventions

DRUGCISPLATIN

Sponsors

Unicancer, Unicancer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.

Secondary

MeasureTime frame
Relapse-free Survival : Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytological diagnostic), biological criteria (confirmed elevation of CA 125 markers according to RUSTIN criteria) or medical imaging criteria (detection of measurable mass, with the new RECIST criteria). The main criteria will be the date at which relapse occurrence is detected., Pain and Quality of Life : Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer). Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis., Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale, Morbidity : Morbidity evaluation will be performed until the 60th day after surgery, taking into account: - deaths - severe complications, Medico-economic study: collection of so

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026