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

Sponsor
University College, London
Study ID
NCT05080556
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Oct 15, 2021
Start date
May 24, 2023
Status verified
Nov 2023
Primary completion
Nov 1, 2026
Completion
Nov 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1 (control) - standard dosing carboplatin
    Arm 1 (Standard Dosing): Carboplatin AUC5 based on nuclear medicine renal clearance.
  • Experimental: Arm 2 (experimental) - adaptive therapy carboplatin according to CA125
    Arm 2 (Adaptive Therapy): Carboplatin dose will be calculated according to the CA125 value.

Primary Outcome Measure

Modified Progression Free Survival (mPFS) [ Time Frame: 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. ]

Central Contacts

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