Trials / Recruiting
RecruitingNCT05080556
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- University College, London · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ovarian Cancer
- Relapsed Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Cancer
- Endometrioid Carcinoma
- High Grade Serous Carcinoma
- Ovary Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Carboplatin | 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. |
Timeline
- Start date
- 2023-05-24
- Primary completion
- 2026-11-01
- Completion
- 2027-11-01
- First posted
- 2021-10-15
- Last updated
- 2024-04-12
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05080556. Inclusion in this directory is not an endorsement.