Ovary CancerPhase 3ICRANCT07068464
ICRA Randomised Controlled Trial
A Phase 3 study testing delayed cytoreduction surgery and interval cytoreduction surgery in people with Ovary Cancer, run by NHS Grampian at 1 site in United Kingdom.
Trial summary
The standard of care for advanced stage epithelial ovarian cancer is primary cytoreduction surgery with the aim of complete cytoreduction, followed by platinum and taxane-based chemotherapy and consideration of maintenance therapy (bevacizumab or Poly ADP-ribose polymerase (PARP)-inhibitor). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- delayed cytoreduction surgery and interval cytoreduction surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2026to 31 Jan 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Women ≥18 years of age.
- Histologically confirmed high grade, serous, or endometrioid ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma.
- International Federation of Gynecologic Oncology (FIGO) 2014 stage IIIA-IVB unsuitable for complete primary cytoreductive surgery because disease unresectable. Assessment of unresectable disease must have been made by staging CT chest abdomen pelvis +/- diagnostic laparoscopy.
- Disease must be deemed resectable after three courses of neoadjuvant chemotherapy.
- Patient must be fit for cytoreduction surgery and chemotherapy.
Who cannot join
- Women undergoing primary and recurrent cytoreductive surgery.
- Mucinous, clear cell, carcinosarcoma, low-grade serous carcinoma, germ cell and sex cord stromal histopathologies.
- Synchronous malignancies.
- Unfit for surgery and or chemotherapy.
- Pregnant or breastfeeding women.
- Delivery of HIPEC at cytoreduction surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Faiza Gaba, +442034567890, faiza.gaba1@abdn.ac.uk
About this study
Official title: Overall Survival Following Interval and Delayed Cytoreduction Surgery in Advanced Stage Ovarian Cancer: a Pragmatic Phase III Randomised Controlled Trial
The standard of care for advanced stage epithelial ovarian cancer is primary cytoreduction surgery with the aim of complete cytoreduction, followed by platinum and taxane-based chemotherapy and consideration of maintenance therapy (bevacizumab or Poly ADP-ribose polymerase (PARP)-inhibitor). Neoadjuvant chemotherapy before and after interval cytoreduction surgery has become an alternative approach as randomized controlled trials have demonstrated non-inferiority of this type of management over primary surgery. In these studies, neoadjuvant chemotherapy was restricted to three to four cycles. However, real-world clinical practice varies, with centres giving more than four pre-operative cycles. The decision to delay surgery is complex and influenced by multiple factors. These include poor performance status, radiological evidence of unresectable sites of disease, or insufficient surgical resources (either lack of surgical expertise operating room availability due to waiting lists) particularly when high complexity surgery is required to achieve complete cytoreduction. International disparities in access to surgical resources between high and low-middle income country settings also results in delays to surgery.
Knowledge gap:
Read more
There is a paucity of data in the setting of extended use of neoadjuvant chemotherapy (more than four cycles). Data on the role of delayed cytoreduction surgery post four cycles are controversial. While some data have shown survival to be similar to that of patients undergoing interval cytoreductive surgery after three cycles,6-12 others have reported poorer prognosis. Conflicting data are due to selection biases such as heterogeneous inclusion criteria, small sample sizes and retrospective study designs. Delaying surgery to after four cycles has the potential to reduce surgical complexity and post-operative morbidity, and increase rates of complete cytoreduction (an independent marker of survival).
Our multi-centre, international, retrospective cohort study (GO SOAR2) of 2498 women from twenty-two centres across twelve countries with advanced stage ovary cancer, showed that interval cytoreduction surgery was associated with statistically significant greater overall survival in comparison to delayed cytoreduction surgery (HR 0.81, p=0.01) but was associated with a higher GO SOAR surgical complexity score and greater surgical morbidity. Our results indicate that early maximum effort cytoreduction surgery with complete cytoreduction in high volume centres with appropriate surgical skill mix and resources, is what is needed to increase overall survival for women with advanced stage ovarian cancer.
We present the study design for a pragmatic phase III superiority randomised controlled trial comparing overall survival following interval and delayed cytoreductive surgery.
Our hypothesis is that overall survival is greater following interval cytoreduction surgery when compared to delayed cytoreduction in women with stage III-IV epithelial ovarian cancer.
- Conditions
- Ovary Cancer
- Being tested
- delayed cytoreduction surgery, interval cytoreduction surgery
- Keywords
- surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed cytoreduction surgeryProcedure or surgery
Delayed cytoreduction surgery is defined as cytoreduction surgery after six cycles of carboplatin and paclitaxel neoadjuvant chemotherapy.
interval cytoreduction surgeryProcedure or surgery
Interval cytoreduction surgery is defined as cytoreduction surgery after three cycles of carboplatin-paclitaxel neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| interval cytoreduction surgery | Active comparator | interval cytoreduction surgery is defined as surgery after 3 cycles of carboplatin and paclitaxel neoadjuvant chemotherapy Receives: Procedure: interval cytoreduction surgery |
| delayed cytoreduction surgery | Experimental | delayed cytoreduction surgery is defined as surgery after 6 cycles of carboplatin and paclitaxel neoadjuvant chemotherapy Receives: Procedure: delayed cytoreduction 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
Measured: 5 years
Secondary outcomes (4)
Progression free survival
Defined from date of diagnosis to date of first recurrence.
Measured: 5 years
Post-operative morbidity
As per Clavien-Dindo classification.
Measured: 30 days post surgery
Peritoneal cancer index (PCI) to assess intra-operative tumour burden and completeness of cytoreduction (CC)
A measure of extent of residual disease at the end of surgery.
Measured: At the end of surgery.
Quality of life as per EQ-5D-5L health-related quality of life questionnaire
Measured using the EQ-5D-5L health-related quality of life questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start31 Jan 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 682 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Faiza Gaba, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068464
- Sponsor's protocol ID
- vF_ICRA
- Acronym
- ICRA
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Survival Following Interval and Delayed Cytoreduction Surgery in Advanced Stage Ovarian Cancer: a Pragmatic Phase III Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07068464
- Acronym / sponsor ID
- ICRA / vF_ICRA
- Conditions
- Ovary Cancer
- Keywords
- surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 682 participants (estimated)
- Lead sponsor
- NHS GrampianOther government
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2034 (estimated)
- First posted
- 16 Jul 2025 (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.
The standard of care for advanced stage epithelial ovarian cancer is primary cytoreduction surgery with the aim of complete cytoreduction, followed by platinum and taxane-based chemotherapy and consideration of maintenance therapy (bevacizumab or Poly ADP-ribose polymerase (PARP)-inhibitor). Neoadjuvant chemotherapy before and after interval cytoreduction surgery has become an alternative approach as randomized controlled trials have demonstrated non-inferiority of this type of management over primary surgery. In these studies, neoadjuvant chemotherapy was restricted to three to four cycles. However, real-world clinical practice varies, with centres giving more than four pre-operative cycles. The decision to delay surgery is complex and influenced by multiple factors. These include poor performance status, radiological evidence of unresectable sites of disease, or insufficient surgical resources (either lack of surgical expertise operating room availability due to waiting lists) particularly when high complexity surgery is required to achieve complete cytoreduction. International disparities in access to surgical resources between high and low-middle income country settings also results in delays to surgery.
Knowledge gap:
There is a paucity of data in the setting of extended use of neoadjuvant chemotherapy (more than four cycles). Data on the role of delayed cytoreduction surgery post four cycles are controversial. While some data have shown survival to be similar to that of patients undergoing interval cytoreductive surgery after three cycles,6-12 others have reported poorer prognosis. Conflicting data are due to selection biases such as heterogeneous inclusion criteria, small sample sizes and retrospective study designs. Delaying surgery to after four cycles has the potential to reduce surgical complexity and post-operative morbidity, and increase rates of complete cytoreduction (an independent marker of survival).
Our multi-centre, international, retrospective cohort study (GO SOAR2) of 2498 women from twenty-two centres across twelve countries with advanced stage ovary cancer, showed that interval cytoreduction surgery was associated with statistically significant greater overall survival in comparison to delayed cytoreduction surgery (HR 0.81, p=0.01) but was associated with a higher GO SOAR surgical complexity score and greater surgical morbidity. Our results indicate that early maximum effort cytoreduction surgery with complete cytoreduction in high volume centres with appropriate surgical skill mix and resources, is what is needed to increase overall survival for women with advanced stage ovarian cancer.
We present the study design for a pragmatic phase III superiority randomised controlled trial comparing overall survival following interval and delayed cytoreductive surgery.
Our hypothesis is that overall survival is greater following interval cytoreduction surgery when compared to delayed cytoreduction in women with stage III-IV epithelial ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interval cytoreduction surgery | Active comparator | Procedure: interval cytoreduction surgeryinterval cytoreduction surgery is defined as surgery after 3 cycles of carboplatin and paclitaxel neoadjuvant chemotherapy |
| delayed cytoreduction surgery | Experimental | Procedure: delayed cytoreduction surgerydelayed cytoreduction surgery is defined as surgery after 6 cycles of carboplatin and paclitaxel neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ≥18 years of age.
- Histologically confirmed high grade, serous, or endometrioid ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma.
- International Federation of Gynecologic Oncology (FIGO) 2014 stage IIIA-IVB unsuitable for complete primary cytoreductive surgery because disease unresectable. Assessment of unresectable disease must have been made by staging CT chest abdomen pelvis +/- diagnostic laparoscopy.
- Disease must be deemed resectable after three courses of neoadjuvant chemotherapy.
- Patient must be fit for cytoreduction surgery and chemotherapy.
Key exclusion criteria (6 listed)
- Women undergoing primary and recurrent cytoreductive surgery.
- Mucinous, clear cell, carcinosarcoma, low-grade serous carcinoma, germ cell and sex cord stromal histopathologies.
- Synchronous malignancies.
- Unfit for surgery and or chemotherapy.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| delayed cytoreduction surgeryDelayed cytoreduction surgery is defined as cytoreduction surgery after six cycles of carboplatin and paclitaxel neoadjuvant chemotherapy. | Procedure or surgery | delayed cytoreduction surgery |
| interval cytoreduction surgeryInterval cytoreduction surgery is defined as cytoreduction surgery after three cycles of carboplatin-paclitaxel neoadjuvant chemotherapy. | Procedure or surgery | interval cytoreduction surgery |
Primary outcome
Overall survival
Time frame: 5 years
Defined from date of diagnosis to date of death
4 secondary outcomes
Progression free survival
Time frame: 5 years
Post-operative morbidity
Time frame: 30 days post surgery
Peritoneal cancer index (PCI) to assess intra-operative tumour burden and completeness of cytoreduction (CC)
Time frame: At the end of surgery.
Quality of life as per EQ-5D-5L health-related quality of life questionnaire
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing delayed cytoreduction surgery and interval cytoreduction surgery in people with Ovary 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faiza Gaba (+442034567890, 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: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.