Clinical trial NCT04830709: Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
Official title: Prospective Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcome Data in Ovarian Cancer Patients Eligible for First-line Platinum-based Chemotherapy and Intended for BRCA/HRD Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Patient reported outcome (PRO),
advanced Ovarian Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)
First posted: 2021-04-05
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approx. 750 patients with newly diagnosed advanced (FIGO stage III or IV) high-grade epithelial ovarian, fallopian-tube, or primary peritoneal cancer are planned to be included in the study in a consecutive manner

Brief summary: 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


Eligibility criteria: 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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Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: date of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months
Secondary outcomes:
measure: Recurrence-free survival (RFS)
timeFrame: time of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months
measure: Progression-/recurrence-free survival rate
timeFrame: percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years
measure: Time to first subsequent therapy (TFST)
timeFrame: time from 1st dose of 1L platinum-based CTX to the 1st dose of subsequent therapy or death of any cause, whichever came first, assessed up to 84 months
measure: Second progression-free survival (PFS2)
timeFrame: time from 1st dose of 1L platinum-based CTX to second disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months
measure: Time to second subsequent therapy (TSST)
timeFrame: time from 1st dose of 1L platinum-based CTX to the 1st dose of second subsequent therapy or death of any cause, whichever came first, assessed up to 84 months
measure: 3rd, 4th, 5th ff. progression-free survival (PFSx = PFS3, 4, 5 ff.)
timeFrame: time from 1st dose of 1L platinum-based CTX to 3rd, 4th, 5th and later disease progression [investigator-assessed according to clinical routine] or death of any cause, whichever came first, assessed up to 84 months
measure: Time to 3rd, 4th, 5th and later subsequent therapy (TST 3rd, 4th, 5th ff.)
timeFrame: defined as time from 1st dose of 1L platinum-based CTX to the 1st dose of 3rd, 4th, 5th and later subsequent therapy or death of any cause, whichever came first, assessed up to 84 months
measure: Overall survival (OS)
timeFrame: time from 1st dose of 1L platinum-based CTX to death of any cause, assessed up to 84 months
measure: Patient-reported health-related quality of life (HRQoL) - EQ-5D questionnaire
timeFrame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
measure: Patient-reported health-related quality of life (HRQoL) - FACT-O questionnaire
timeFrame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
measure: Patient-reported health-related quality of life (HRQoL) - MOSTv2 questionnaire
timeFrame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
measure: Patient-reported health-related quality of life (HRQoL) - PGI-S questionnaire
timeFrame: during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
Other outcomes:
measure: Patient's expectations/needs
timeFrame: at baseline, once a year during routine visits, up to 84 months
measure: physician's expectations on therapy
timeFrame: at baseline, once a year during routine visits, up to 84 months
measure: BRCA mutation testing behavior
timeFrame: documented at baseline
measure: HRD testing behavior
timeFrame: documented at baseline
measure: Safety: Collection of Adverse Events (AE)
timeFrame: during routine visits, up to 84 months
measure: Patient population
timeFrame: at baseline and changes at time points of expected routine visits, up to 84 months
Locations:
city: Aachen
country: Germany
facility: Research Site
city: Amberg
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Baden-Baden
country: Germany
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bielefeld
country: Germany
facility: Research Site
city: Bielefeld
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Boeblingen
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Borna
country: Germany
facility: Research Site
city: Bottrop
country: Germany
facility: Research Site
city: Brandenburg an der Havel
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Donauwoerth
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Eggenfelden
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Fuerth
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Goettingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hanau
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Limburg
country: Germany
facility: Research Site
city: Luebeck
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Moenchengladbach
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Nuernberg
country: Germany
facility: Research Site
city: Nuertingen
country: Germany
facility: Research Site
city: Offenburg
country: Germany
facility: Research Site
city: Osnabrueck
country: Germany
facility: Research Site
city: Pforzheim
country: Germany
facility: Research Site
city: Plauen
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Rheine
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Rotenburg (W Mme)
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Schwaebisch Hall
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Singen
country: Germany
facility: Research Site
city: Solingen
country: Germany
facility: Research Site
city: Stendal
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Torgau
country: Germany
facility: Research Site
city: Traunstein
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Winnenden
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Wolfsburg
country: Germany
facility: Research Site
city: Worms
country: Germany
facility: Research Site
city: Wuppertal
country: Germany
facility: Research Site
Study officials:
References: