Actively Recruiting
Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
Led by University College, London · Updated on 2024-04-12
80
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
A
Anticancer Fund, Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.
CONDITIONS
Official Title
Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 6518 years
- ECOG performance status 0-2
- Histologically confirmed high grade serous or high grade endometrioid carcinoma of ovary, fallopian tube, or peritoneum
- Most recent treatment included platinum (cisplatin or carboplatin)
- Previous treatment with a PARP inhibitor
- Response to most recent platinum treatment by CT, MRI, or GCIG CA125 criteria
- Disease relapse confirmed by CT or MRI at least 6 months after last platinum chemotherapy
- Measurable disease by RECIST v1.1 on CT within 28 days prior to randomisation or meeting GCIG CA125 progression criteria
- CA125 level 65100 iU/l at screening
- Agree to provide research blood samples at specified times
- Able to start treatment within 28 days post randomisation
- Adequate bone marrow, liver, and renal function
- Postmenopausal or WOCBP with negative pregnancy test and use of contraception
- Willing and able to consent and comply with study procedures
You will not qualify if you...
- Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous and clear-cell carcinomas
- Need for combination chemotherapy regimens
- Known hypersensitivity to carboplatin
- Persistent grade 2 or higher adverse events from prior treatment (except alopecia and neuropathy)
- Use of other investigational agents or participation in other trials within 28 days
- Major surgery within 14 days prior to treatment start
- Other medical conditions or laboratory findings posing high risk or contraindications
- Psychological, psychiatric, social, or medical conditions interfering with study compliance
- Malignancy treated within last 5 years except certain adequately treated cancers
- Symptomatic uncontrolled brain or meningeal metastases
- Spinal cord compression without stable disease for 28 days
- Pregnant or breastfeeding women; WOCBP must use effective contraception during and 6 months after treatment
- Inability to attend or comply with treatment or follow-up scheduling
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University College London Hospitals
London, United Kingdom
Actively Recruiting
Research Team
A
ACTOv Trial Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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