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

简要总结

主要结局

次要结局

• Acceptability (1/2)(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.)
• Compliance(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 (2/2)(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)(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))
• Further treatment (1/3)(Additional treatment of patients who progress will be described by trial arm, this will include the time-to-next treatment (measured from randomisation).)
• Acceptability (2/2)(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)(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)(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)
• Adverse events (1/2)(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 (2/2) - EQ-5D ((mobility, self-care, usual activities, pain/discomfort, anxiety/depression, a single summary index and a visual analogue scale)(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(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, through study completion, an average of 1 year.)
• Further treatment (2/3)(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)(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, censored at the date last seen (estimate 2 years but can be up to 4 years))