Health TrialsbyHealthPanel

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

ConditionsOvarian CancerRelapsed Ovarian CancerFallopian Tube CancerPeritoneal CancerEndometrioid CarcinomaHigh Grade Serous CarcinomaOvary Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity College, London

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous & clear-cell carcinomas

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Arm 1 (control) - standard dosing carboplatinActive comparator 1 intervention
Group B: Arm 2 (experimental) - adaptive therapy carboplatin according to CA125Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Modified Progression Free Survival (mPFS)

Measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) but comparing CT scans to the baseline CT rather than the radiological nadir), clinical progression or death from any cause (in the absence of progression)

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.

Secondary outcomes

1

Acceptability (1/2)

the number of eligible patients approached who accept randomisation and continue to receive treatment

Time frame
From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the number of patients approached who accept randomisation.
2

Acceptability (2/2)

the proportion of eligible patients approached who accept randomisation and continue to receive treatment

Time frame
From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the percent of patients approached who accept randomisation.
3

Deliverability (1/2)

the number of treatment cycles that are delivered as per protocol, described by trial arm

Time frame
Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
4

Deliverability (2/2)

the proportion of treatment cycles that are delivered as per protocol, described by trial arm

Time frame
Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

Anticancer Fund, Belgium

Collaborator

JP Moulton Charitable Foundation

Collaborator

Barts & The London NHS Trust

Collaborator

Source ClinicalTrials.gov
Apply now