Ovarian cancer Cancer Malignant neoplasm of ovary
Conditions
Interventions
Participants will receive treatment with rucaparib 600 mg BD until progression or unacceptable toxicity. No additional monitoring or investigations for safety or efficacy over standard practice will b
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women where a decision has been made to start rucaparib as part of standard care for maintenance treatment recurrent ovarian cancer following to platinum based chemotherapy and they have not yet started treatment 2. Written informed consent 3. Ability and willingness to complete questionnaires in English 4. Meet institutional criteria for treatment in standard practice
Exclusion criteria
Exclusion criteria: 1. Prior treatment with a poly ADP ribose polymerase (PARP) inhibitor 2. Current treatment with another maintenance therapy for ovarian cancer 3. Participation in another trial of an investigational medicinal product (IMP) (participation in another observational or sample collection trial may be possible if both Sponsors agree and the burden on the patient is acceptable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse events measured by CTC v05 at all study visits: baseline, at the start of every treatment cycle on treatment (initially every 4 weeks), at progression of the cancer or end of treatment and 1 to 2 months post progression of the cancer 2. Proportion of patients who require one or more dose reductions due to toxicity, defined as the number of patients who are prescribed a dose lower than the licensed starting dose at some points in their treatment divided by the total number of patients. Doses prescribed will be determined from prescribing records at the start of every treatment cycle (initially every 4 weeks) 3. Proportion of patients who require one or more dose interruptions due to toxicity, defined as the number of patients who require a dose interruption at some point in their treatment divided by the total number of patients. Dose interruptions will be determined from prescribing records at the start of every treatment cycle (initially every 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival, defined as the time from start of rucaparib to date of progression by radiological criteria (physician assessed) 2. Progression-free survival (CA125), defined as the time from the start of rucaparib to date of progression by GCIG CA125 criteria 3. Time to first subsequent therapy, defined as the time from the start of rucaparib to first day of subsequent therapy 4. Overall survival, defined as the time from the start of rucaparib to date of death. Patients will be censored at last known follow up 5. Type of subsequent therapy name and schedule of subsequent systemic therapy derived from prescribing records, dose and schedule of any radiotherapy, type and date of surgical procedure determined from clinical records, assessed every 3 months after the end of treatment/progression of the cancer, whichever is later, until the end of the study 6. Time to second subsequent therapy, defined as the time from the start of rucaparib to the first day of second subsequent therapy 7. Cancer-related quality of life measured using EORTS QLQ C30 at cycle 1 day 1, cycle 2 day 1, cycle 4 day 1, cycle 7 day 1, end of treatment, at progression and post progression 8. General health-related quality of life measured using EQ-5D at cycle 1 day 1, cycle 2 day 1, cycle 4 day 1, cycle 7 day 1, end of treatment, at progression and post progression | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactClare;Rosalind Dolan;Glasspool
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Outcome results
None listed