ICRA Randomised Controlled Trial

Launched by NHS GRAMPIAN · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for surgery in women with advanced ovarian cancer. Usually, women with this type of cancer have surgery first to remove as much of the tumor as possible, followed by chemotherapy. However, some women receive chemotherapy before surgery to shrink the tumor, making surgery easier. This study aims to find out whether having surgery after three cycles of chemotherapy (called interval surgery) leads to better overall survival compared to waiting longer and having surgery after more than four cycles (delayed surgery).

Women who might be eligible for this trial are those aged 18 or older with specific types of advanced ovarian, fallopian tube, or primary peritoneal cancer that cannot be fully removed by initial surgery. They must have had some chemotherapy before surgery and be healthy enough for both surgery and chemotherapy. Participants will be randomly assigned to have surgery either after three cycles of chemotherapy or later, after more cycles. The goal is to see which approach helps women live longer, while also considering how complicated the surgery is and potential side effects. This trial is important because it could help doctors choose the best treatment plan, especially in places where surgical resources and expertise vary.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women ≥18 years of age.
• • 2. Histologically confirmed high grade, serous, or endometrioid ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma.
• • 3. International Federation of Gynecologic Oncology (FIGO) 2014 stage IIIA-IVB unsuitable for complete primary cytoreductive surgery because disease unresectable. Assessment of unresectable disease must have been made by staging CT chest abdomen pelvis +/- diagnostic laparoscopy.
• • 4. Disease must be deemed resectable after three courses of neoadjuvant chemotherapy.
• • 5. Patient must be fit for cytoreduction surgery and chemotherapy.
• Exclusion Criteria:
• • 1. Women undergoing primary and recurrent cytoreductive surgery.
• • 2. Mucinous, clear cell, carcinosarcoma, low-grade serous carcinoma, germ cell and sex cord stromal histopathologies.
• • 3. Synchronous malignancies.
• • 4. Unfit for surgery and or chemotherapy.
• • 5. Pregnant or breastfeeding women.
• • 6. Delivery of HIPEC at cytoreduction surgery.