Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Female Patients aged 18 to 75 years.

• International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.

• Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.

• ECOG performance status: 0 or 1.

• Resectable disease by laparoscopic assessment after 3 cycles of NACT.

• Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.

• Estimated life expectancy of \> 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.

Locations
Other Locations
Egypt
Elshatby Maternity University Hospital
RECRUITING
Alexandria
Contact Information
Primary
Hayat Sharaf, MsC
h_mohammed14@alexmed.edu.eg
00201025774942
Backup
Alaa Elzarkaa, PhD
A_elzarka09@alexmed.edu.eg
00201008296264
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2029-03-20
Participants
Target number of participants: 250
Treatments
Experimental: delayed interval cytoreduction surgery (DICS)
delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks
Active_comparator: Early interval cytoreduction surgery (EICS)
Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks
Related Therapeutic Areas
Sponsors
Leads: Alexandria University

This content was sourced from clinicaltrials.gov