Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Anticancer Fund, Belgium | OTHER |
| JP Moulton Charitable Foundation | OTHER |
| Barts & The London NHS Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (control) - standard dosing carboplatin | Active Comparator | Arm 1 (Standard Dosing): Carboplatin AUC5 based on nuclear medicine renal clearance. |
|
| Arm 2 (experimental) - adaptive therapy carboplatin according to CA125 | Experimental | Arm 2 (Adaptive Therapy): Carboplatin dose will be calculated according to the CA125 value. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability (1/2) | the number of eligible patients approached who accept randomisation and continue to receive treatment | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ACTOv Trial Coordinator | Contact | 02076794466 | ctc.actov@ucl.ac.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospitals | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39806715 | Derived | Mukherjee UA, Hockings H, Counsell N, Patel A, Narayanan P, Wilkinson K, Dhanda H, Robinson K, McNeish I, Anderson ARA, Miller R, Gourley C, Graham T, Lockley M. Study protocol for Adaptive ChemoTherapy for Ovarian cancer (ACTOv): 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. BMJ Open. 2024 Dec 22;14(12):e091262. doi: 10.1136/bmjopen-2024-091262. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acceptability (2/2) |
the proportion of eligible patients approached who accept randomisation and continue to receive treatment |
| 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. |
| Deliverability (1/2) | the number of treatment cycles that are delivered as per protocol, described by trial arm | 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 |
| Deliverability (2/2) | the proportion of treatment cycles that are delivered as per protocol, described by trial arm | 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 |
| Compliance | total cumulative carboplatin dose will be calculated for each patient over time on treatment, and described by trial arm | Total cumulative carboplatin dose will be calculated for each patient over time on treatment (max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 18 weeks and 36 weeks respectively |
| Adverse events (1/2) | adverse events will be categorised using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The number of patients who suffer a grade 3 or 4 toxicity at any time, and the maximum grade of toxicity for each adverse event term, will be described by trial arm | Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively) |
| Adverse events (2/2) | adverse events will be categorised using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The percentage of patients who suffer a grade 3 or 4 toxicity at any time, and the maximum grade of toxicity for each adverse event term, will be described by trial arm | Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively) |
| Quality of life (1/2) - EORTC questionnaire (assessing the quality of life of patients with ovarian cancer) | measured using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC questionnaires): Quality of Life cancer 30 (QLQ-C30) (suitable for all cancer types) and Qualify of life questionnaire (QLQ-OV28 (ovarian cancer-specific)) in scale of 4 (1 is not very much and 4 very much) | At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years) |
| Quality of life (2/2) - EQ-5D ((mobility, self-care, usual activities, pain/discomfort, anxiety/depression, a single summary index and a visual analogue scale) | measured using European Quality of life questionnaire five dimensions (EQ-5D (descriptive profile of health state)) in scale of 5 (1 is no problem and 5 is extreme problem) | At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years) |
| Fear of progression | measured using Fear of progression questionnaire (FOP-Q SF) in scale of 1 to 5 where 1 is never and 5 is very often | At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years) |
| CA125 | measured at baseline, 3-weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up | Measured at baseline, 3 weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up, through study completion, an average of 1 year. |
| Further treatment (1/3) | of patients who progress will be described by trial arm including the time-to-next treatment (measured from randomisation) | Additional treatment of patients who progress will be described by trial arm, this will include the time-to-next treatment (measured from randomisation). |
| Further treatment (2/3) | of patients who progress will be described by trial arm including the time treatment received (measured from randomisation) | Additional treatment of patients who progress will be described by trial arm, this will include the time treatment received (measured from randomisation) |
| Further treatment (3/3) | of patients who progress will be described by trial arm including the time response to this treatment (measured from randomisation) | Additional treatment of patients who progress will be described by trial arm, this will include the time response to this treatment (measured from randomisation) |
| Overall survival | measured from the date of randomisation to the date of death from any cause. Patients who are event-free will be censored at the date last seen | Measured from the date of randomisation to the date of death from any cause, censored at the date last seen (estimate 2 years but can be up to 4 years) |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D018269 | Carcinoma, Endometrioid |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided