NCT05704621

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
32mo left

Started Dec 2023

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Dec 2023Dec 2028

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2028

Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

January 19, 2023

Last Update Submit

March 3, 2025

Conditions

Ovarian CancerDrug Related Neoplasm/Cancer

Keywords

recurrent ovarian cancerPARP inhibitor resistancesecondary cytoreductive surgeryprogression during PARP inhibitor maintenance

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    interval between date of randomization and the date of second relapse/progression or death, whatever occurs first

    Up to 2 year

Secondary Outcomes (1)

  • Overall survival

    Up to 2 year

Other Outcomes (4)

  • 30-day post-operative complications

    From the operation until after 30 days

  • Time to first subsequent anticancer therapy

    Up to 1 year

  • Time to second subsequent anticancer therapy

    Up to 2 year

  • +1 more other outcomes

Study Arms (2)

secondary cytoreductive surgery followed by chemotherapy

EXPERIMENTAL

surgery arm

Procedure: secondary cytoreductive surgeryDrug: chemotherapy

chemotherapy

ACTIVE COMPARATOR

no surgery arm

Drug: chemotherapy

Interventions

secondary cytoreductive surgeryPROCEDURE

Maximum effort cytoreductive surgery

Also known as: secondary cytoreductive surgery followed by chemotherapy
secondary cytoreductive surgery followed by chemotherapy
chemotherapyDRUG

six cycles of platinum-based chemotherapy +/- bevacizumab

Also known as: no surgery and only chemotherapy
chemotherapysecondary cytoreductive surgery followed by chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39164041DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Hyun-Woong Cho, MD. PhD.

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Woong Cho, MD. PhD.

CONTACT

82-2-2626-3228limpcho82@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized superiority trial (Surgery versus No Surgery)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

December 28, 2028

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)