Ovarian CancerGO SOAR2NCT05523804
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer
An observational study of Ovarian Cancer, run by NHS Grampian at 1 site in United Kingdom.
Trial summary
To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- interval cytoreductive surgery, delayed cytoreductive surgery and no surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Aug 2022to 31 Dec 2024
- 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: women with stage III-IV ovarian cancer
Who may be able to join
- Women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (>5 cycles of chemotherapy alone.
Who cannot join
- Women undergoing recurrent cytoreductive surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal London Hospital
London, E1 1FR
Faiza Gaba, +442035942053, faiza.gaba1@abdn.ac.uk
About this study
Official title: Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)
To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.
Read the detailed description
Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following >5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.
- Conditions
- Ovarian Cancer
- Being tested
- interval cytoreductive surgery, delayed cytoreductive surgery, no surgery
- Keywords
- survival, morbidity, cytoreduction, disparities
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval cytoreductive surgeryProcedure or surgery
cytoreductive surgery after 3-4 cycles of chemotherapy
delayed cytoreductive surgeryProcedure or surgery
surgery after >5 cycles of chemotherapy
no surgeryOther
no cytoreductive surgery (>5 cycles of chemotherapy alone)
| Study group | Role | What they receive |
|---|---|---|
| interval cytoreductive surgery | women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery Receives: Procedure: interval cytoreductive surgery | |
| delayed cytoreductive surgery | women with stage III-IV ovarian cancer, undergoing delayed (>5 cycles of chemotherapy) cytoreductive surgery Receives: Procedure: delayed cytoreductive surgery | |
| no surgery | women with stage III-IV ovarian cancer, undergoing >5 cycles of chemotherapy alone (no cytoreductive surgery) Receives: Other: no surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
defined from date of diagnosis to date of death by any cause or loss to follow-up
Measured: 15 years
progression free survival
defined from date of diagnosis to date of first recurrence
Measured: 15 years
facilitator/barriers to access to cytoreductive surgery
topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally
Measured: 15 years
Secondary outcomes (2)
Post-operative morbidity
as per Clavien-Dindo classification
Measured: within 30 days from date of surgery
Resectability rates
R0 = no visible disease, R1 = <10mm visible residual disease, R2 = >10mm visible residual disease
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start26 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Collaborators
- University of Aberdeen, Barts & The London NHS Trust, Queen Mary University of London
- Responsible party
- Principal investigator, Faiza Gaba, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523804
- Sponsor's protocol ID
- 5719
- Acronym
- GO SOAR2
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gaba F, Ash K, Blyuss O, Bizzarri N, Kamfwa P, Ramirez PT, Kotsopoulos IC, Chandrasekaran D, Gomes N, Butler J, Nobbenhuis M, Ind T, Heath O, Barton D, Jeyarajah A, Brockbank E, Lawrence A, Dilley J, Manchanda R, Phadnis S, Soar GO. Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative). Int J Gynecol Cancer. 2022 Dec 5;32(12):1606-1610. doi: 10.1136/ijgc-2022-004101.
PubMed 36379595
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)
- ClinicalTrials.gov ID
- NCT05523804
- Acronym / sponsor ID
- GO SOAR2 / 5719
- Conditions
- Ovarian Cancer
- Keywords
- survival, morbidity, cytoreduction, disparities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- NHS GrampianOther government
- Collaborators
- University of Aberdeen, Barts & The London NHS Trust, Queen Mary University of London
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Aug 2022 (actual)
- 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.
To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.
Detailed description
Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following >5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| interval cytoreductive surgery | – | Procedure: interval cytoreductive surgerywomen with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery |
| delayed cytoreductive surgery | – | Procedure: delayed cytoreductive surgerywomen with stage III-IV ovarian cancer, undergoing delayed (>5 cycles of chemotherapy) cytoreductive surgery |
| no surgery | – | Other: no surgerywomen with stage III-IV ovarian cancer, undergoing >5 cycles of chemotherapy alone (no cytoreductive surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with stage III-IV ovarian cancer
Key inclusion criteria (1 listed)
- Women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (>5 cycles of chemotherapy alone.
Key exclusion criteria (1 listed)
- Women undergoing recurrent cytoreductive surgery.
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 |
|---|---|---|
| interval cytoreductive surgerycytoreductive surgery after 3-4 cycles of chemotherapy | Procedure or surgery | interval cytoreductive surgery |
| delayed cytoreductive surgerysurgery after >5 cycles of chemotherapy | Procedure or surgery | delayed cytoreductive surgery |
| no surgeryno cytoreductive surgery (>5 cycles of chemotherapy alone) | Other | no surgery |
Primary outcome
overall survival
Time frame: 15 years
defined from date of diagnosis to date of death by any cause or loss to follow-up
progression free survival
Time frame: 15 years
defined from date of diagnosis to date of first recurrence
facilitator/barriers to access to cytoreductive surgery
Time frame: 15 years
topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally
2 secondary outcomes
Post-operative morbidity
Time frame: within 30 days from date of surgery
Resectability rates
Time frame: at time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 36379595Gaba F, Ash K, Blyuss O, Bizzarri N, Kamfwa P, Ramirez PT, Kotsopoulos IC, Chandrasekaran D, Gomes N, Butler J, Nobbenhuis M, Ind T, Heath O, Barton D, Jeyarajah A, Brockbank E, Lawrence A, Dilley J, Manchanda R, Phadnis S, Soar GO. Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative). Int J Gynecol Cancer. 2022 Dec 5;32(12):1606-1610. doi: 10.1136/ijgc-2022-004101.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by NHS Grampian at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faiza Gaba (+442035942053, faiza.gaba1@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 15 years). The study lists 3 primary outcomes in all. 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 NCT05523804, which also lists 1 linked publication.
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 31 Aug 2022.