RecruitingPhase 2NCT05080556

Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer

A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer

Sponsor

University College, London

Enrollment

80 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Fallopian Tube Cancer Ovary Cancer Peritoneal Cancer Relapsed Ovarian Cancer Endometrioid Carcinoma High Grade Serous Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying an adaptive chemotherapy approach (where treatment is adjusted based on how well the tumor is responding) for high-grade ovarian cancer that has returned at least 6 months after prior platinum-based chemotherapy. **You may be eligible if...** - You are a woman 18 or older with high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer - Your cancer came back at least 6 months after your last platinum chemotherapy - You have previously received a PARP inhibitor - Your cancer showed a response to the most recent platinum treatment - Your CA125 level is at least 100 IU/L at screening - Your bone marrow, liver, and kidney function are adequate **You may NOT be eligible if...** - Your cancer is platinum-resistant (came back within 6 months) - You have not previously received PARP inhibitor therapy - You are pregnant or breastfeeding - You have uncontrolled serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Treatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2.

Locations(1)

University College London Hospitals

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05080556

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