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

Browse trials for

• Carcinoma 6,762
• Ovarian Neoplasms 2,691
• Carcinoma, Ovarian Epithelial 1,617
• Fallopian Tube Neoplasms 715
• Cystadenocarcinoma, Serous 123
• Carcinoma, Endometrioid 76

Study arms

• Active comparator
  Arm 1 (control) - standard dosing carboplatin

  Arm 1 (Standard Dosing): Carboplatin AUC5 based on nuclear medicine renal clearance.

  Drug: Carboplatin

• Experimental
  Arm 2 (experimental) - adaptive therapy carboplatin according to CA125

  Arm 2 (Adaptive Therapy): Carboplatin dose will be calculated according to the CA125 value.

  Drug: Carboplatin

Interventions

• DrugCarboplatin

  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.

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

5. Compliance

   total cumulative carboplatin dose will be calculated for each patient over time on treatment, and described by trial arm

   Time frame: 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

6. 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

   Time frame: 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)

7. 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

   Time frame: 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)

8. 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)

   Time frame: 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)

9. 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)

   Time frame: 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)

10. 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

    Time frame: 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)

11. CA125

    measured at baseline, 3-weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up

    Time frame: 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.

12. Further treatment (1/3)

    of patients who progress will be described by trial arm including the time-to-next treatment (measured from randomisation)

    Time frame: Additional treatment of patients who progress will be described by trial arm, this will include the time-to-next treatment (measured from randomisation).

13. Further treatment (2/3)

    of patients who progress will be described by trial arm including the time treatment received (measured from randomisation)

    Time frame: Additional treatment of patients who progress will be described by trial arm, this will include the time treatment received (measured from randomisation)

14. Further treatment (3/3)

    of patients who progress will be described by trial arm including the time response to this treatment (measured from randomisation)

    Time frame: Additional treatment of patients who progress will be described by trial arm, this will include the time response to this treatment (measured from randomisation)

15. 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

    Time frame: 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)