Surgery Timing After Chemotherapy for Ovarian Cancer
Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer
Recruiting
N/AInterventional Study
Ovarian Epithelial Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Alexandria University · Other
Who this trial is looking for
This trial is looking for women with advanced ovarian cancer who are not eligible for immediate surgery. Participants will receive chemotherapy and then have surgery at different times to see which is better for survival.
Are You a Good Fit for This Trial?
Rules you outSevere comorbidities
You may be able to join if
I am a female between 18 and 75 years old.
I have advanced ovarian cancer that is not suitable for immediate surgery.
I have high-grade serous ovarian, fallopian tube, or peritoneal cancer.
I have an ECOG performance status of 0 or 1.
I can have my cancer assessed as resectable after 3 cycles of chemotherapy.
I have adequate health in terms of blood, lungs, heart, liver, and kidneys.
My estimated life expectancy is more than 3 months.
I have a low or moderate level of other health issues.
You may not be able to join if
I have metastatic ovarian cancer.
I have a type of ovarian cancer that is not high-grade serous.
I am pregnant or breastfeeding.
I have had another invasive cancer in the last 5 years.
I had a stroke in the last 6 months.
I have uncontrolled health issues or cannot take chemotherapy.
My cancer got worse during chemotherapy.
I have a worsening health performance status.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 chemother…
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Female Patients aged 18 to 75 years.
2. International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
3. Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
4. ECOG performance status: 0 o…
Inclusion Criteria:
1. Female Patients aged 18 to 75 years.
2. International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
3. Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
4. ECOG performance status: 0 or 1.
5. Resectable disease by laparoscopic assessment after 3 cycles of NACT.
6. Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
7. 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.
Exclusion Criteria:
1. Metastatic ovarian carcinoma.
2. Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
3. Presence of pregnancy or breast-feeding.
4. History of other invasive malignancies in the previous 5 years.
5. History of a recent \< 6 month cerebrovascular accident.
6. Uncontrolled systemic disease or contraindication to chemotherapy.
7. Progressive disease on NACT.
8. Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
9. Severe comorbidities (ACCI \>= 4)
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