Ovarian CancerPhase 2SOCCER-PNCT05704621
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
A Phase 2 study testing secondary cytoreductive surgery and chemotherapy in people with Ovarian Cancer and Drug Related Neoplasm/Cancer, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Drug Related Neoplasm/Cancer
- What is being tested?
- secondary cytoreductive surgery and chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2023to 28 Dec 2028
- Phase
- Phase 2
- 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
- Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
- Progression-free interval of at least 6 months after end of last platinum- containing therapy,
- Progressed during PARP inhibitor maintenance
- Women aged ≥ 18 years
- Complete resection of the tumor seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned
- A positive AGO-score or iMODEL+PET/CT
- Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative.
- Patients who have given their signed and written informed consent and their consent to data transmission and -processing.
Who cannot join
- Patients with non-epithelial tumors as well as borderline tumors.
- Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
- More than one prior chemotherapy
- Patients with second, third, or later recurrence
- Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
- Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapy
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- Only palliative surgery planned
- Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
- Any concomitant disease not allowing surgery and/or chemotherapy
- Any medical history indicating excessive peri-operative risk
- Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
- No assessable archival tumor tissue
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
Jung-Yun Lee
About this study
Official title: A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.
Read the detailed description
The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.
- Conditions
- Ovarian Cancer, Drug Related Neoplasm/Cancer
- Being tested
- secondary cytoreductive surgery, chemotherapy
- Keywords
- recurrent ovarian cancer, PARP inhibitor resistance, secondary cytoreductive surgery, progression during PARP inhibitor maintenance
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secondary cytoreductive surgeryProcedure or surgery
Also called secondary cytoreductive surgery followed by chemotherapy
Maximum effort cytoreductive surgery
chemotherapyDrug
Also called no surgery and only chemotherapy
six cycles of platinum-based chemotherapy +/- bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| secondary cytoreductive surgery followed by chemotherapy | Experimental | surgery arm Receives: Procedure: secondary cytoreductive surgery; Drug: chemotherapy |
| chemotherapy | Active comparator | no surgery arm Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
interval between date of randomization and the date of second relapse/progression or death, whatever occurs first
Measured: Up to 2 year
Secondary outcomes (1)
Overall survival
from date of randomisation until death
Measured: Up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Dec 2023
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2028 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized superiority trial (Surgery versus No Surgery)
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd, Chong Kun Dang Pharmaceutical Corp., Yonsei University, KGOG: Korean Gynaelogical Onology Group, Korea, Japanese Gynecologic Oncology Group, Asia-Pacific Gynecologic Oncology Trials Group
- Responsible party
- Principal investigator, Hyun Woong Cho, Korea University Guro Hospital
- Investigators
- Hyun-Woong Cho, MD. PhD., Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704621
- Sponsor's protocol ID
- KGOG3067/JGOG3036/APGOT-OV11
- Acronym
- SOCCER-P
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho HW, Kim HS, Park JY, Lee YY, Lim MC, Lee SJ, Min KJ, Eoh KJ, Lee KB, Kim MK, Song JY, Shim SH, Ji YI, Song YJ, Chang SJ, Kim MK, Abe A, Kobayashi Y, Kajiyama H, Shimada M, Okamoto A, Ng JS, Lee JY. A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on a PARP inhibitor as first-line maintenance therapy: the SOCCER-P study (KGOG 3067/JGOG 3036/APGOT-OV11). Int J Gynecol Cancer. 2024 Nov 4;34(11):1809-1812. doi: 10.1136/ijgc-2024-005838.
PubMed 39164041
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
- ClinicalTrials.gov ID
- NCT05704621
- Acronym / sponsor ID
- SOCCER-P / KGOG3067/JGOG3036/APGOT-OV11
- Conditions
- Ovarian Cancer, Drug Related Neoplasm/Cancer
- Keywords
- recurrent ovarian cancer, PARP inhibitor resistance, secondary cytoreductive surgery, progression during PARP inhibitor maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd, Chong Kun Dang Pharmaceutical Corp., Yonsei University, KGOG: Korean Gynaelogical Onology Group, Korea, Japanese Gynecologic Oncology Group, Asia-Pacific Gynecologic Oncology Trials Group
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 30 Jan 2023 (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.
This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.
Detailed description
The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized superiority trial (Surgery versus No Surgery)
| Arm | Type | Receives |
|---|---|---|
| secondary cytoreductive surgery followed by chemotherapy | Experimental | Procedure: secondary cytoreductive surgery, Drug: chemotherapysurgery arm |
| chemotherapy | Active comparator | Drug: chemotherapyno surgery arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
- Progression-free interval of at least 6 months after end of last platinum- containing therapy,
- Progressed during PARP inhibitor maintenance
- Women aged ≥ 18 years
- Complete resection of the tumor seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned
Key exclusion criteria (12 listed)
- Patients with non-epithelial tumors as well as borderline tumors.
- Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
- More than one prior chemotherapy
- Patients with second, third, or later recurrence
- Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
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 |
|---|---|---|
| secondary cytoreductive surgeryAlso: secondary cytoreductive surgery followed by chemotherapyMaximum effort cytoreductive surgery | Procedure or surgery | secondary cytoreductive surgery followed by chemotherapy |
| chemotherapyAlso: no surgery and only chemotherapysix cycles of platinum-based chemotherapy +/- bevacizumab | Drug | chemotherapy, secondary cytoreductive surgery followed by chemotherapy |
Primary outcome
progression-free survival
Time frame: Up to 2 year
interval between date of randomization and the date of second relapse/progression or death, whatever occurs first
1 secondary outcome
Overall survival
Time frame: Up to 2 year
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 6 Mar 2025.
- Derived from this study: PubMed 39164041Cho HW, Kim HS, Park JY, Lee YY, Lim MC, Lee SJ, Min KJ, Eoh KJ, Lee KB, Kim MK, Song JY, Shim SH, Ji YI, Song YJ, Chang SJ, Kim MK, Abe A, Kobayashi Y, Kajiyama H, Shimada M, Okamoto A, Ng JS, Lee JY. A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on a PARP inhibitor as first-line maintenance therapy: the SOCCER-P study (KGOG 3067/JGOG 3036/APGOT-OV11). Int J Gynecol Cancer. 2024 Nov 4;34(11):1809-1812. doi: 10.1136/ijgc-2024-005838.
- Individual participant dataSharing planned: No
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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.
Hyun-Woong Cho, MD. PhD. principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing secondary cytoreductive surgery and chemotherapy in people with Ovarian Cancer and Drug Related Neoplasm/Cancer, run by Korea University Guro Hospital at 1 site in South Korea.
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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Mar 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hyun-Woong Cho, MD. PhD. (82-2-2626-3228, limpcho82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: Up to 2 year). 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 NCT05704621, 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 6 Mar 2025.