A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patients

Phase 1

• Conditions: stage III epithelial ovarian cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003346-17-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-18
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 530

Inclusion Criteria

- signed and written informed consent
- age =18
- candidate for primary CRS, in whom a complete cytoreduction, or cytoreducion with no more than 2.5 mm residual disease is considered feasible
- histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
- fit for major surgery, ASA 1 or ASA 2
- WHO performance status 0 t/m2
- adequate bone marrow, hepatic and renal function

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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.history of previous malignancies within 5 years prior to inclusion
2.FIGO stage IV disease
3.if complete primary cytoreduction is impossible
4.patients who received prior treatment for the current malignancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine the beneficial effect of primary cytoreductive surgery (CRS) in combination with HIPEC (treatment arm) compared to primary CRS without HIPEC (standard arm), in patients with FIGO stage III ovarian cancer, who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm;Secondary Objective: -To show the addition of HIPEC improves recurrence-free survival<br>-To evaluate the toxicity and morbidity of both treatment arms<br>-To evaluate the quality of life of the treatment arm compared to the standard arm <br>-To assess genetic profiles predictive of tumor response in patients with stage III ovarian cancer undergoing primary CRS with or without HIPEC<br>-To assess an economic- and cost evaluation of the procedure ;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: after 1 year of follow up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Recurrence-free survival<br>-The toxicity and morbidity of both treatment arms<br>-The quality of life of both treatment arms<br>-Economic- and cost evaluation of the procedure;Timepoint(s) of evaluation of this end point: RFS, QoL and cost effectiveness: after 6 years (after one year of follow up)<br><br>safety: after 30 days after last treatment