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| Name | Class |
|---|---|
| North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.) | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PARPi maintenance cohort (PMC) | patients who received at least one dose of PARPi as 1L MTX after 1L platinum-based CTX | ||
| Bevacizumab maintenance cohort (BMC) | 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) | patients who never received any 1L MTX treatment (PARPi or bevacizumab) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Böblingen | Germany | 71032 | Germany | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Patient population | Patient population described on the basis of:
| at baseline and changes at time points of expected routine visits, up to 84 months |
| Göttingen |
| Germany |
| 37075 |
| Germany |
| Research Site | Nürtingen | Germany | 72622 | Germany |
| Research Site | Osnabrück | Germany | 49076 | Germany |
| Research Site | Rotenburg (Wümme) | Germany | 27356 | Germany |
| Research Site | Aachen | 52074 | Germany |
| Research Site | Amberg | 92224 | Germany |
| Research Site | Aschaffenburg | 63739 | Germany |
| Research Site | Augsburg | 86156 | Germany |
| Research Site | Bayreuth | 95445 | Germany |
| Research Site | Berlin | 10367 | Germany |
| Research Site | Berlin | 10967 | Germany |
| Research Site | Berlin | 12101 | Germany |
| Research Site | Berlin | 12559 | Germany |
| Research Site | Berlin | 13187 | Germany |
| Research Site | Berlin | 13353 | Germany |
| Research Site | Berlin | 13509 | Germany |
| Research Site | Berlin | 14163 | Germany |
| Research Site | Berlin | 14169 | Germany |
| Research Site | Bielefeld | 33604 | Germany |
| Research Site | Bielefeld | 33611 | Germany |
| Research Site | Bochum | 44791 | Germany |
| Research Site | Bonn | 53113 | Germany |
| Research Site | Borna | 4552 | Germany |
| Research Site | Bottrop | 46236 | Germany |
| Research Site | Brandenburg an der Havel | 14770 | Germany |
| Research Site | Bremen | 28205 | Germany |
| Research Site | Coburg | 96450 | Germany |
| Research Site | Cologne | 50931 | Germany |
| Research Site | Cologne | 50935 | Germany |
| Research Site | Dessau | 6947 | Germany |
| Research Site | Dortmund | 44137 | Germany |
| Research Site | Dresden | 1307 | Germany |
| Research Site | Düsseldorf | 40489 | Germany |
| Research Site | Eggenfelden | 84307 | Germany |
| Research Site | Erfurt | 99084 | Germany |
| Research Site | Fürth | 90766 | Germany |
| Research Site | Gelnhausen | 63571 | Germany |
| Research Site | Gera | 7548 | Germany |
| Research Site | Halle | 6110 | Germany |
| Research Site | Hamburg | 20246 | Germany |
| Research Site | Hamburg | 22307 | Germany |
| Research Site | Hamburg | 22457 | Germany |
| Research Site | Hanau | 63450 | Germany |
| Research Site | Heilbronn | 74078 | Germany |
| Research Site | Hildesheim | 31134 | Germany |
| Research Site | Homburg | 66421 | Germany |
| Research Site | Itzehoe | 25524 | Germany |
| Research Site | Jena | 7747 | Germany |
| Research Site | Kiel | 24116 | Germany |
| Research Site | Krefeld | 47805 | Germany |
| Research Site | Leipzig | 4103 | Germany |
| Research Site | Limburg | 65549 | Germany |
| Research Site | Lübeck | 23562 | Germany |
| Research Site | Magdeburg | 39108 | Germany |
| Research Site | Magdeburg | 39130 | Germany |
| Research Site | Mainz | 55131 | Germany |
| Research Site | Mönchengladbach | 41061 | Germany |
| Research Site | Mutlangen | 73557 | Germany |
| Research Site | München | 80638 | Germany |
| Research Site | Münster | 48145 | Germany |
| Research Site | Nuremberg | 90419 | Germany |
| Research Site | Offenburg | 77654 | Germany |
| Research Site | Pforzheim | 75179 | Germany |
| Research Site | Plauen | 08525 | Germany |
| Research Site | Potsdam | 14467 | Germany |
| Research Site | Recklinghausen | 45659 | Germany |
| Research Site | Regensburg | 93053 | Germany |
| Research Site | Rheine | 48431 | Germany |
| Research Site | Rosenheim | 83022 | Germany |
| Research Site | Rostock | 18059 | Germany |
| Research Site | Saarlouis | 66740 | Germany |
| Research Site | Siegen | 57072 | Germany |
| Research Site | Singen | 78224 | Germany |
| Research Site | Solingen | 42653 | Germany |
| Research Site | Stendal | 39576 | Germany |
| Research Site | Stralsund | 18439 | Germany |
| Research Site | Stuttgart | 70174 | Germany |
| Research Site | Stuttgart | 70199 | Germany |
| Research Site | Torgau | 4860 | Germany |
| Research Site | Traunstein | 83278 | Germany |
| Research Site | Ulm | 89075 | Germany |
| Research Site | Villingen-Schwenningen | 78052 | Germany |
| Research Site | Wiesbaden | 65199 | Germany |
| Research Site | Winnenden | 71364 | Germany |
| Research Site | Witten | 58452 | Germany |
| Research Site | Wolfsburg | 38440 | Germany |
| Research Site | Worms | 67550 | Germany |
| Research Site | Wuppertal | 42283 | Germany |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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