Efficacy of intraperitoneal chemohyperthermia associated with cytoreductive surgery in the peritoneal tube epithelial neoplasia / advanced-stage ovarian

Stage IIIC unresectable epithelial ovarian/tubal cancer with partial or complete response after 1st line neoadjuvant chemotherapy (3 cycles CBDCA+Paclitaxel): a phase 3 prospective randomized study comparing cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CDDP+Paclitaxel) + 3 cycles CBDCA+Paclitaxel vs cytoreductive surgery alone + 3 cycles CBDCA+Paclitaxel. - CHORINE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002616-22-IT

Enrollment

Registered

2012-06-07

Start date

2012-05-30

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

EPITHELIAL OVARIAN/TUBAL CANCER MedDRA version: 14.1 Level: HLT Classification code 10033121 Term: Ovarian and fallopian tube cysts and neoplasms System Organ Class: 100000004872

Interventions

Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 0015663-27-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Female adult women (18 to 70 years old) 2.patients, with EOC (FIGO stage IIIc, with a Fagotti modified Laparoscopic Scoring System = 4 3. who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy; 4. performance status (ECOG) 0, 1 or 2 5. signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: refusing to sign an informed consent; • age > 70 years and age 35; • impossibility of an adequate follow-up; • presence of other active neoplasms; • active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol; • extraabdominal metastases (Stage IV) ; • performance status (ECOG)>2; • complete bowel obstruction; • Abnormal bone marrow indices or renal and liver function; • ASA IV or V.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare two-years disease-free survival of CRS and HIPEC (CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).;Secondary Objective: ////;Primary end point(s): The present study will compare CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) in Stage IIIC inoperable epithelial tubal/ovarian cancer with partial or complete response after neoadjuvant chemotherapy (3 cycles CDDP+Paclitaxel), followed by adjuvant chemotherapy in terms of two-years disease-free survival from the date of randomization.;Timepoint(s) of evaluation of this end point: 2 years-----	—

Measure

Time frame

Main Objective: To compare two-years disease-free survival of CRS and HIPEC (CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).;Secondary Objective: ////;Primary end point(s): The present study will compare CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) in Stage IIIC inoperable epithelial tubal/ovarian cancer with partial or complete response after neoadjuvant chemotherapy (3 cycles CDDP+Paclitaxel), followed by adjuvant chemotherapy in terms of two-years disease-free survival from the date of randomization.;Timepoint(s) of evaluation of this end point: 2 years-----

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Secondary

Measure	Time frame
Secondary end point(s): 1.to evaluate one-year, three- and five-years disease-free survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE); 2. to evaluate one month, one-year, three- and five-years overall survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE); 3.to evaluate toxicity induced by HIPEC using the NCI CTC criteria (APPENDIX 8). 4. to evaluate one month and six months morbidity induced by the CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) using the Common Terminology Criteria for Adverse Events v4.03 (CTCAE 4.03 - http://evs.nci.nih.gov/ftp1/CTCAE/About.html); 5.to evaluate the duration of operation (minutes) CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), defined as operating time, anesthesia time, or operating room time; 6. return of bowel function (days) after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), subdivided in: time until first stool, introduction of liquid or solid diet; 7. length of hospital stay (days) of CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE); 8. return to normal activity (days), after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) i.e. time until return to full activity, work, or sport; 9. six months and one year QOL, using the Standard Form 36 (SF-36 v1.0, APPENDIX 9); 10. percentage of patients in both arms completing the scheduled postoperative chemotherapy; 11. correspondence between pre-randomization clinical/radiologic/laboratory evaluation and intraoperative findings;Timepoint(s) of evaluation of this end point: p.to 1: 1-3 e 5 anni p.to 2: 1-3 e 5 anni	—

Measure

Time frame

Secondary end point(s): 1.to evaluate one-year, three- and five-years disease-free survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE); 2. to evaluate one month, one-year, three- and five-years overall survival from the date of randomization after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE); 3.to evaluate toxicity induced by HIPEC using the NCI CTC criteria (APPENDIX 8). 4. to evaluate one month and six months morbidity induced by the CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) using the Common Terminology Criteria for Adverse Events v4.03 (CTCAE 4.03 - http://evs.nci.nih.gov/ftp1/CTCAE/About.html); 5.to evaluate the duration of operation (minutes) CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), defined as operating time, anesthesia time, or operating room time; 6. return of bowel function (days) after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE), subdivided in: time until first stool, introduction of liquid or solid diet; 7. length of hospital stay (days) of CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE); 8. return to normal activity (days), after CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) i.e. time until return to full activity, work, or sport; 9. six months and one year QOL, using the Standard Form 36 (SF-36 v1.0, APPENDIX 9); 10. percentage of patients in both arms completing the scheduled postoperative chemotherapy; 11. correspondence between pre-randomization clinical/radiologic/laboratory evaluation and intraoperative findings;Timepoint(s) of evaluation of this end point: p.to 1: 1-3 e 5 anni p.to 2: 1-3 e 5 anni

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Countries

Italy

Contacts

Public ContactU.S.C CHIRURGIA I

A.O OSPEDALI RIUNITI

lansaloni@ospedaliriuniti.bergamo.it035269368

Outcome results

None listed

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