NCT06404671Recruiting
Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer
Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery
Source: ClinicalTrials.gov · Last updated 8 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 1 May 2024
- Start date
- 15 Sept 2023
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Alexandria University
- Diseases
- Ovarian cancer
- NCT number
- NCT06404671
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 15 Sept 2023 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of other invasive malignancies in the previous 5 years.
- History of a recent \< 6 month cerebrovascular accident.
- Uncontrolled systemic disease or contraindication to chemotherapy.
- Progressive disease on NACT.
Other
- Metastatic ovarian carcinoma.
- Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
- Presence of pregnancy or breast-feeding.
- Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
- Severe comorbidities (ACCI \>= 4)
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elshatby Maternity University Hospital Coordinator of this site? Confirm its status | Alexandria | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.