Platinum-sensitive Recurrent Serous Ovarian CancerOSCANCT02262273

OSCA - Olaparib Standard of CAre Study

An observational study of Platinum-sensitive Recurrent Serous Ovarian Cancer, run by AstraZeneca at 199 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Platinum-sensitive Recurrent Serous Ovarian Cancer
What is being tested?: Data Collection
How many people: 2,123 participants
Where: 199 sitesin 13 countries
Study dates: Oct 2014to Apr 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: platinum-sensitive recurrent serous ovarian cancer patients

Who may be able to join

First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date.
At least 18 years of age on the index date.
Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer.
Patients can be either alive or deceased at the time of medical record abstraction.

Who cannot join

1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.

Trial locations and contacts

199 sites in 13 countries.

Country

City, postcode or hospital

199 sites in 13 countries

Italy48 sites

Research Site
Alessandria
Research Site
Aosta
Research Site
Ariano Irpino
Research Site
Avellino
Research Site
Bari
Research Site
Brescia
Research Site
Brindisi
Research Site
Caltagirone
Research Site
Candiolo
Research Site
Carbonia
Research Site
Castelfranco Veneto
Research Site
Castellana Grotte
Research Site
Castellaneta
Research Site
Catania
Research Site
Figline Valdarno
Research Site
Franca
Research Site
Genova
Research Site
Gorizia
Research Site
Gravina di Catania
Research Site
Ivrea
Research Site
Latina
Research Site
Latisana
Research Site
Lecce
Research Site
Lido di Ostia
Research Site
Manduria
Research Site
Manerbi
Research Site
Milan
Research Site
Monselice
Research Site
Monserrato
Research Site
Monza
Research Site
Naples
Research Site
Orbassano
Research Site
Padova
Research Site
Palmanova
Research Site
Ponte A Niccheri
Research Site
Portogruaro
Research Site
Reggio Calabria
Research Site
Rieti
Research Site
Rionero in Vulture
Research Site
Roma
Research Site
San Gavino Monreale
Research Site
Santorso VI
Research Site
Seriate
Research Site
Sesto San Giovanni
Research Site
Solofra
Research Site
Taranto
Research Site
Torino
Research Site
Trieste

Other trials in Italy

France29 sites

Research Site
Aix-en-Provence
Research Site
Ajaccio
Research Site
Auxerre
Research Site
Besançon
Research Site
Béziers
Research Site
Bordeaux
Research Site
Bourg-en-Bresse
Research Site
Brest
Research Site
Caen
Research Site
Chambéry
Research Site
Colombes
Research Site
Grenoble
Research Site
Libourne
Research Site
Longjumeau
Research Site
Lyon
Research Site
Marseille
Research Site
Mont-de-Marsan
Research Site
Montbéliard
Research Site
Montpellier
Research Site
Mulhouse
Research Site
Nantes
Research Site
Narbonne
Research Site
Quimper
Research Site
Rennes
Research Site
Saint-Pierre-du-Mont
Research Site
Strasbourg
Research Site
Toulouse
Research Site
Tours
Research Site
Villejuif

Other trials in France

Germany27 sites

Research Site
Bad Godesberg
Research Site
Berlin
Research Site
Chemnitz
Research Site
Cologne
Research Site
Düsseldorf
Research Site
Erlangen
Research Site
Essen
Research Site
Frankfurt
Research Site
Frankfurt am Main
Research Site
Hagen
Research Site
Hamburg
Research Site
Heidelberg
Research Site
Heilbronn
Research Site
Karlsruhe
Research Site
Kiel
Research Site
Köthen
Research Site
Leverkusen
Research Site
München
Research Site
Nuremberg
Research Site
Osnabrück
Research Site
Passau
Research Site
Ratingen
Research Site
Saarlouis
Research Site
Stuttgart
Research Site
Ulm
Research Site
Velbert
Research Site
Wetzlar

Other trials in Germany

United Kingdom19 sites

Research Site
Basingstoke
Research Site
Bradford
Research Site
Brighton
Research Site
Bristol
Research Site
Cambridge
Research Site
Canterbury
Research Site
Glasgow
Research Site
Gloucester
Research Site
Leeds
Research Site
London
Research Site
Manchester
Research Site
Oxford
Research Site
Plymouth
Research Site
Reading
Research Site
Sheffield
Research Site
Southend-on-Sea
Research Site
Taunton
Research Site
Wales
Research Site
Wolverhampton

Other trials in United Kingdom

Spain14 sites

Research Site
Alicante
Research Site
Alzira, Valencia
Research Site
Barcelona
Research Site
Elche
Research Site
Las Palmas
Research Site
Madrid
Research Site
Málaga
Research Site
Murcia
Research Site
Ourense
Research Site
Segovia
Research Site
Seville
Research Site
Terrassa
Research Site
Toledo
Research Site
Valencia

Other trials in Spain

Switzerland14 sites

Research Site
Aarau
Research Site
Allschwil
Research Site
Baden
Research Site
Basel
Research Site
Bern
Research Site
Frauenfeld
Research Site
Liestal
Research Site
Lucerne
Research Site
Rorschach
Research Site
Sankt Gallen
Research Site
Sion
Research Site
Sursee
Research Site
Wetzikon
Research Site
Zurich

Other trials in Switzerland

Portugal12 sites

Research Site
Barreiro
Research Site
Cascais
Research Site
Coimbra
Research Site
Covilha
Research Site
Lisbon
Research Site
Martinho Do Bispo
Research Site
Portimão
Research Site
Porto
Research Site
S. Martinho Do Porto
Research Site
Santa Maria da Feira
Research Site
Setúbal
Research Site
Vila Nova de Gaia

Other trials in Portugal

Australia9 sites

Research Site
Ballarat
Research Site
Birtinya
Research Site
Campbelltown
Research Site
East Melbourne
Research Site
Mandurah, Western Australia
Research Site
South Brisbane
Research Site
St Leonards
Research Site
Victoria
Research Site
Waratah

Other trials in Australia

Israel9 sites

Research Site
Afula
Research Site
Haifa
Research Site
Jerusalem
Research Site
Netanya
Research Site
Petah Tikva
Research Site
Rehovot
Research Site
Saint Holon
Research Site
Tel Aviv
Research Site
Tel HaShomer

Other trials in Israel

Canada8 sites

Research Site
Alberta
Research Site
Charlottetown
Research Site
Mississauga
Research Site
Montreal
Research Site
Ottawa
Research Site
Red Deer
Research Site
Toronto
Research Site
Vancouver

Other trials in Canada

Netherlands5 sites

Research Site
Dordrecht
Research Site
Enschede
Research Site
Leiderdorp
Research Site
Nijmegen
Research Site
Purmerend

Other trials in Netherlands

Belgium3 sites

Research Site
Edegem
Research Site
Namur
Research Site
Sint-Niklaas

Other trials in Belgium

South Korea2 sites

Research Site
Gyeonggi-do
Research Site
Seoul

Other trials in South Korea

About this study

Official title: Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study

This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

Conditions: Platinum-sensitive Recurrent Serous Ovarian Cancer
Being tested: Data Collection
Keywords: women, platinum sensitive, recurrent, serous, ovarian cancer, BRCA, PARP, Olaparib
Medical subject headings: Recurrence, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Data CollectionOther
Colleciton of data from medical records only

Study groups in NCT02262273
Study group	Role	What they receive
Serous ovarian cancer:		Women with platinum-sensitive recurrent serous ovarian cancer Receives: Other: Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Best response to therapy and date of response for each subsequent therapy line post-index
Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria).
Measured: Data will be collected retrospectively from medical records

Secondary outcomes (2)

Progression-free survival, by therapy line
Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria)
Measured: Data will be collected retrospectively from medical records
Overall survival, calculated from various time points
From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest
Measured: Data will be collected retrospectively from medical records

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Apr 2016

First posted13 Oct 2014 (estimated)
Study startOct 2014
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Platinum-sensitive Recurrent Serous Ovarian CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 2,123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02262273
Sponsor's protocol ID: D0816R00004
Acronym: OSCA
Status last verified: Feb 2017
First submitted: 6 Oct 2014
Last updated: 1 Mar 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Active, not recruitingPhase 2
Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
Ovarian Cancer, Low Grade Serous Carcinoma
Active, not recruitingPhase 3
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma
Not yet recruitingPhase 3
A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03)
Fallopian Tube Cancer, Primary Peritoneal Cancer
Active, not recruitingPhase 2
Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
Fallopian Tube Endometrioid Tumor, Fallopian Tube High Grade Serous Adenocarcinoma

All Platinum-sensitive Recurrent Serous Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study
ClinicalTrials.gov ID: NCT02262273
Acronym / sponsor ID: OSCA / D0816R00004
Conditions: Platinum-sensitive Recurrent Serous Ovarian Cancer
Keywords: women, platinum sensitive, recurrent, serous, ovarian cancer, BRCA, PARP, Olaparib
Study type: Observational
Recruitment status: Completed
Enrolment: 2,123 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: RTI Health Solutions, A+A Healthcare Marketing Research, Freelance CRA (FCRA)
Study start: Oct 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 13 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Serous ovarian cancer:	–	Other: Data CollectionWomen with platinum-sensitive recurrent serous ovarian cancer

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: platinum-sensitive recurrent serous ovarian cancer patients

Key inclusion criteria (4 listed)

First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date.
At least 18 years of age on the index date.
Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer.
Patients can be either alive or deceased at the time of medical record abstraction.

Key exclusion criteria (1 listed)

1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Data CollectionColleciton of data from medical records only	Other	Serous ovarian cancer:

Primary outcome

Best response to therapy and date of response for each subsequent therapy line post-index
Time frame: Data will be collected retrospectively from medical records
Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria).

2 secondary outcomes

Progression-free survival, by therapy line
Time frame: Data will be collected retrospectively from medical records
Overall survival, calculated from various time points
Time frame: Data will be collected retrospectively from medical records

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
D0816R00004\_CSR\_Synopsis\_23Feb2017.pdfLink provided by the sponsor.

Related trials for Platinum-sensitive Recurrent Serous Ovarian Cancer

RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Active, not recruitingPhase 2
Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
Ovarian Cancer, Low Grade Serous Carcinoma
Active, not recruitingPhase 3
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma
Not yet recruitingPhase 3
A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03)
Fallopian Tube Cancer, Primary Peritoneal Cancer
Active, not recruitingPhase 2
Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
Fallopian Tube Endometrioid Tumor, Fallopian Tube High Grade Serous Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicoletta Colombo, MD study director

Steering Committee/Advisory Board Members

Laurence Gladieff, MD study director

Steering Committee/Advisory Board Members

Sven Mahner, MD study director

Steering Committee/Advisory Board Members

199 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Platinum-sensitive Recurrent Serous Ovarian Cancer, run by AstraZeneca at 199 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in Italy, France, Germany, United Kingdom, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best response to therapy and date of response for each subsequent therapy line post-index (time frame: Data will be collected retrospectively from medical records). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02262273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.