Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade … (NCT05080556) | Clinical Trial Compass
RecruitingPhase 2
Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
United Kingdom80 participantsStarted 2023-05-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patients aged ≥18 years
✓. ECOG performance status 0-2
✓. Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum
✓. Most recent regimen must have included platinum (cisplatin or carboplatin)
✓. Must have previously received a PARP inhibitor
✓. 6\. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria
✓. Pre-trial CT or MRI-confirmed disease relapse ≥ 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy
✓. Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria)
Exclusion criteria
✕
What they're measuring
1
Modified Progression Free Survival (mPFS)
Timeframe: From the date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
✕. Patients requiring treatment with combination chemotherapy regimens
✕. Patients with a known hypersensitivity to carboplatin
✕. Persisting ≥ grade 2 CTCAE v5 adverse events/ toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.
✕. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation.
✕. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.
✕. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.
✕. Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.