Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial.

Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial. - CarcinoHIPEC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001715-31-ES

Enrollment

126

Registered

2011-09-28

Start date

2011-12-13

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Peritoneal carcinomatosis from ovarian cancer, fallopian tube or primary peritoneal carcinoma.

Interventions

Trade Name: Cisplatino 1mg/ml , concentrado para solución para perfusión Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 15663-27-1 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma. - Residual tumor 6 months. - Voluntary and signed written infromed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63

Exclusion criteria

Exclusion criteria: - Extraperitoneal tumor disease. - Suboptimal debulking (residual tumor > 2.5 mm). - Previous history of other malignancies (excluding skin) - Intestinal obstruction at the time of evaluation. - Renal failure. - Heart failure. - Uncontrolled infection. - Pregnant or lactating patients. - In recurrences, disease-free interval < 6 months. - Hypersensitivity to cispñatin previously. - Have been subjected to a procedure previously HIPEC. - Denial of diseased part of the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate whether the administration of HIPEC with Cisplatin (75 miligrams per square meter of body surface) after surgical cytoreduction in women with ovarian , tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.;Secondary Objective: - Evaluation of overall survival. - Study of morbidity. - Evaluation of quality of life related to the procedure. - Study of Ex vivo correlation.;Primary end point(s): Efficacy Variable: difference in disease-free survival of at least 20 % for the experimental group (HIPEC) versus conventional treatment group (surgery alone). Safety Variable: Profile of adverse events in both groups.;Timepoint(s) of evaluation of this end point: Every three mounths during two years and half and every six mounths during two years and half.	—

Measure

Time frame

Main Objective: Investigate whether the administration of HIPEC with Cisplatin (75 miligrams per square meter of body surface) after surgical cytoreduction in women with ovarian , tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.;Secondary Objective: - Evaluation of overall survival. - Study of morbidity. - Evaluation of quality of life related to the procedure. - Study of Ex vivo correlation.;Primary end point(s): Efficacy Variable: difference in disease-free survival of at least 20 % for the experimental group (HIPEC) versus conventional treatment group (surgery alone). Safety Variable: Profile of adverse events in both groups.;Timepoint(s) of evaluation of this end point: Every three mounths during two years and half and every six mounths during two years and half.

—

Secondary

Measure	Time frame
Secondary end point(s): Overrall survival Morbimortality Quality of life to the procedure Ex vivo correlation;Timepoint(s) of evaluation of this end point: Every three mounths during two years and half and every six mounths during two years and half.	—

Countries

Spain

Contacts

Public ContactClinical Trials Information

Fundación para la Formación e Investigación Sanitaria de la Región de Murcia

isabel.vasallo@carm.es34968381290

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026