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

Ovarian Cancer Clinical Trial

— SCOUT-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830709
• Other study ID #: D0817R00030
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: December 31, 2031

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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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Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Germany	Research Site	Aachen
Germany	Research Site	Amberg
Germany	Research Site	Aschaffenburg
Germany	Research Site	Augsburg
Germany	Research Site	Baden-Baden
Germany	Research Site	Bayreuth
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld
Germany	Research Site	Bielefeld
Germany	Research Site	Bochum
Germany	Research Site	Boeblingen
Germany	Research Site	Borna
Germany	Research Site	Bottrop
Germany	Research Site	Brandenburg an der Havel
Germany	Research Site	Bremen
Germany	Research Site	Coburg
Germany	Research Site	Donauwoerth
Germany	Research Site	Dortmund
Germany	Research Site	Dresden
Germany	Research Site	Duesseldorf
Germany	Research Site	Eggenfelden
Germany	Research Site	Erfurt
Germany	Research Site	Fuerth
Germany	Research Site	Gera
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hanau
Germany	Research Site	Heilbronn
Germany	Research Site	Hildesheim
Germany	Research Site	Homburg
Germany	Research Site	Jena
Germany	Research Site	Kiel
Germany	Research Site	Koeln
Germany	Research Site	Koeln
Germany	Research Site	Krefeld
Germany	Research Site	Leipzig
Germany	Research Site	Limburg
Germany	Research Site	Luebeck
Germany	Research Site	Magdeburg
Germany	Research Site	Magdeburg
Germany	Research Site	Mainz
Germany	Research Site	Moenchengladbach
Germany	Research Site	Muenster
Germany	Research Site	Nuernberg
Germany	Research Site	Nuertingen
Germany	Research Site	Offenburg
Germany	Research Site	Osnabrueck
Germany	Research Site	Pforzheim
Germany	Research Site	Plauen
Germany	Research Site	Potsdam
Germany	Research Site	Regensburg
Germany	Research Site	Rheine
Germany	Research Site	Rosenheim
Germany	Research Site	Rostock
Germany	Research Site	Rotenburg (Wümme)
Germany	Research Site	Saarlouis
Germany	Research Site	Schwaebisch Hall
Germany	Research Site	Siegen
Germany	Research Site	Singen
Germany	Research Site	Solingen
Germany	Research Site	Stendal
Germany	Research Site	Stralsund
Germany	Research Site	Stuttgart
Germany	Research Site	Stuttgart
Germany	Research Site	Torgau
Germany	Research Site	Traunstein
Germany	Research Site	Ulm
Germany	Research Site	Villingen-Schwenningen
Germany	Research Site	Wiesbaden
Germany	Research Site	Winnenden
Germany	Research Site	Witten
Germany	Research Site	Wolfsburg
Germany	Research Site	Worms
Germany	Research Site	Wuppertal

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's expectations/needs	Patient's expectations/needs for support/information/education regarding the disease itself and the current therapy (systemic therapies during surgery, CTX, MTX, FU, long-term survivor) as determined by unstandardized questionnaire partially based on EXPRESSION IV questionnaire and open questioning	at baseline, once a year during routine visits, up to 84 months
Other	physician's expectations on therapy	data on the physician's expectations on systemic therapies (unstandardized questionnaire) will be collected after the physician has enrolled the first patient (FPI) and afterwards annually	at baseline, once a year during routine visits, up to 84 months
Other	BRCA mutation testing behavior	BRCA mutation testing behavior during clinical routine will be assessed with respect to initiator, time of test initiation, type of sample, variants detected, and turnaround time (TAT: duration from request of the BRCA mutation analysis or receipt of the sample in the laboratory, whichever comes later, and the release of the report). Details will be retrospectively assessed for patients with an already existing test result at study inclusion	documented at baseline
Other	HRD testing behavior	HRD testing behavior during clinical routine will be assessed with respect to initiator, type of sample, type of test, HRD status result, HRD score, and turnaround time (TAT: duration from request of HRD analysis or receipt of the sample in the laboratory, whichever comes later, and the release of the report). Details will be retrospectively assessed for patients with an already existing test result at study inclusion.	documented at baseline
Other	Safety: Collection of Adverse Events (AE)	Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness	during routine visits, up to 84 months
Other	Patient population	Patient population described on the basis of: Baseline characteristics; Disease history; Social status; Comorbidities and concomitant treatments	at baseline and changes at time points of expected routine visits, up to 84 months
Primary	progression-free survival (PFS)	The primary outcome is progression-free survival (PFS) defined as time from 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause. Methods and intervals for tumor assessments are at the discretion of the treating physician. Details on progression incl. the procedure used to confirm progression (e.g. symptoms, ultrasound, x-ray, CT, MRI) will be captured in the eCRF.	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	Recurrence-free survival (RFS)	Recurrence-free survival (RFS) is time from 1st dose of 1L platinum-based CTX to disease recurrence (investigator-assessed according to clinical routine) or death of any cause defined as in patients with no evidence of disease (NED) following platinum-based CTX	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
Secondary	Progression-/recurrence-free survival rate	Progression-/recurrence-free survival rate is defined as the percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years derived by Kaplan-Meier methods in the full analysis set/subset of patients with NED; Patients within NED subset will be considered as long-term disease-free survivors (potentially cured) if they are disease free for the whole period of 7 years	percentage of patients without disease progression/recurrence alive at 2, 3, 5 and 7 years
Secondary	Time to first subsequent therapy (TFST)	Time to first subsequent therapy (TFST) is defined as time from 1st dose of 1L platinum-based CTX to the 1st dose of subsequent therapy or death of any cause;	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
Secondary	Second progression-free survival (PFS2)	Second progression-free survival (PFS2) is defined as time from 1st dose of 1L platinum-based CTX to second disease progression (investigator-assessed according to clinical routine) or death of any cause. Methods and intervals of tumor assessments are at the discretion of the treating physician and will be recorded in the eCRF	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
Secondary	Time to second subsequent therapy (TSST)	Time to second subsequent therapy (TSST) as time from 1st dose of 1L platinum-based CTX to the 1st dose of second subsequent therapy or death of any cause	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
Secondary	3rd, 4th, 5th ff. progression-free survival (PFSx = PFS3, 4, 5 ff.)	3rd, 4th, 5th ff. progression-free survival (PFSx = PFS3, 4, 5 ff.) is defined as 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). Methods and intervals of tumor assessments are at the discretion of the treating physician and will be recorded in the eCRF	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
Secondary	Time to 3rd, 4th, 5th and later subsequent therapy (TST 3rd, 4th, 5th ff.)	Time to 3rd, 4th, 5th and later subsequent therapy (TST 3rd, 4th, 5th ff.) is 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	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
Secondary	Overall survival (OS)	Overall survival (OS) is defined as time from 1st dose of 1L platinum-based CTX to death of any cause	time from 1st dose of 1L platinum-based CTX to death of any cause, assessed up to 84 months
Secondary	Patient-reported health-related quality of life (HRQoL) - EQ-5D questionnaire	The EQ-5D is a standardized measure of health status applicable to a wide range of health conditions and treatments designed by the EuroQoL Group (EQ). It consists of the EQ-5D descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with each dimension having 5 levels (5L), and the EQ visual analogue scale (EQ VAS).	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
Secondary	Patient-reported health-related quality of life (HRQoL) - FACT-O questionnaire	Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Quality of life of women with OC is assessed by means of the FACT-O questionnaire. It contains questions addressing the most frequent problems of cancer patients: physical well-being, social/family well-being, emotional well-being, functional well-being, as well as additional concerns specific to OC (such as female-specific concerns and abdominal problems)	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
Secondary	Patient-reported health-related quality of life (HRQoL) - MOSTv2 questionnaire	Measure of Ovarian Symptoms and Treatment concerns Version 2 (MOSTv2) The MOST quantifies patient-reported symptom burden, adverse effects, and symptom benefit in OC patients. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months
Secondary	Patient-reported health-related quality of life (HRQoL) - PGI-S questionnaire	Patient global impression of severity of cancer symptoms (PGI-S) is a one-item scale to assess a patient's impression of disease severity on a four-point scale from normal to severe.	during observation period of the study: primary therapy/maintenance, recurrence/progression, subsequent treatments, up to 84 months