Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer (SCOUT-1)

AstraZeneca

Status: Enrolling

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04830709

D0817R00030

Details and patient eligibility

About

This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on:

• outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured,
• patient's follow-up (FU) during and after MTX therapy,
• patient-reported outcomes (PROs), experiences and needs,
• physician's experience,
• BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy,
• patient selection for different 1L systemic treatment approaches,
• use and safety of drugs,
• treatment sequence in case of recurrence

Enrollment: 750 estimated patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed written informed consent
2. Women aged ≥ 18 years
3. Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer)
4. For patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment
5. BRCA mutation test (routinely analyzed germline and/or somatic BRCA1/2 status alone or as part of HRD status determination) already performed or initiated/intended
6. First-line platinum-based chemotherapy planned or a maximum of 3 cycles already received with no sign of disease progression. Total number of cycles after enrollment should be decided individually for each single patient by the treating physician. In case of neoadjuvant chemotherapy and interval debulking surgery, the patient should be enrolled after completion of surgical procedure and at the time of the 1st post-surgery cycle of platinum-based chemotherapy.
7. Willing and able to report PROs electronically
8. Women of childbearing potential must use two forms of reliable contraception according to standard of care

Exclusion criteria

1. Pregnancy or breast-feeding 2. Current or planned participation in an interventional clinical trial on first-line treatment of OC 3. Current or upcoming systemic treatment of any tumor other than OC 4. Not eligible for platinum-based chemotherapy or early progress during the cycles of first-line platinum-based chemotherapy prior to enrollment

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Trial design

750 participants in 3 patient groups

PARPi maintenance cohort (PMC)

Description:

patients who received at least one dose of PARPi as 1L MTX after 1L platinum-based CTX

Bevacizumab maintenance cohort (BMC)

Description:

patients who continue to receive at least one dose of bevacizumab after 1L platinum-based CTX and who have not received PARPi MTX treatment

No maintenance cohort (NMC)

Description:

patients who never received any 1L MTX treatment (PARPi or bevacizumab)