Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer

NCT07171528 | Recruiting Phase 2

• 1 other identifier: NCC2025-0092
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To compare outcomes between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy

Conditions

Ovarian Cancer

Keywords

ovarian cancer; Recurrent ovarian cancer; Epithelial Ovarian Cancer; platinum sensitive recurrent ovarian cancer; secondarycytoreductive surgery

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  From randomization to time of first progression or death

  From randomization to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years

Secondary Outcomes (8)

• Overall survival

  From randomization to the date of death from any cause, assessed up to 5 years

• Cancer specific survival

  From date of randomization until the date of death due to ovarian cancer, assessed up to 5 years

• Adverse Event

  1 day after surgery, recovery period (3-5 weeks after surgery), up to 6 weeks after completion of chemotherapy

• Health-related quality of life (EORTC-QLQ-C30)

  Over the 5 year surveillance period

• Health-related quality of life (EORTC-QLQ-OV28)

  Over the 5 year surveillance period

Study Arms (2)

No-Secondary Cytoreductive Surgery

NO INTERVENTION

* Secondary cytoreductive surgery in this study will be performed in patients who have undergone 3 cycles of chemotherapy and shown a response (Complete response, partial response, or stable disease). * The chemotherapy regimen used before and after the intervention will be the same. Chemotherapy for patients with progressive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that recurs at least 6 months after platinum-based chemotherapy will be used. * Both the CRS group and the control group will receive adjuvant chemotherapy for 3-6 cycles after enrollment. * The following chemotherapy regimens are allowed and correspond to the standard treatments for platinum-sensitive recurrent ovarian cancer: * Carboplatin/Paclitaxel ± Bevacizumab * Carboplatin/Liposomal Doxorubicin ± Bevacizumab * Carboplatin/Gemcitabine ± Bevacizumab * Carboplatin/Topotecan * Cisplatin/Topotecan * Carboplatin/Docetaxel * Cisplatin/Docetaxel

Secondary Cytoreductive Surgery

EXPERIMENTAL

Surgery will only be performed in patients assigned to the experimental arm of the study. The goal of secondary cytoreductive surgery is to achieve complete tumor reduction by removing all visible residual tumors (Complete cytoreduction with no macroscopic residual disease), and this effort should be the top priority.

Procedure: Secondary Cytoreductive Surgery

Interventions

Secondary Cytoreductive Surgery PROCEDURE

Surgery will only be performed in patients assigned to the experimental arm of the study. The goal of secondary cytoreductive surgery is to achieve complete tumor reduction by removing all visible residual tumors (Complete cytoreduction with no macroscopic residual disease), and this effort should be the top priority.

Secondary Cytoreductive Surgery

Eligibility Criteria

• Age: 19 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• Patients with recurrent ovarian cancer who have received platinum-based chemotherapy (3 or 4 cycles) and were deemed unsuitable for secondary cytoreductive surgery due to a negative AGO score according to the DESKTOP-III trial.
• Patients with recurrent ovarian cancer who have responded to chemotherapy (Complete Response, Partial Response, or Stable Disease).
• The patient's disease must have recurred after platinum-based therapy, and be defined as platinum-sensitive, meaning progression occurred more than 6 months (180 days) after the last administration of platinum-based therapy.
• Patients aged 19 years or older at the time of providing informed written consent.
• Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 within 28 days prior to clinical trial allocation.
• Women who are medically unable to conceive or, if of childbearing potential, must agree to follow contraception guidelines during the treatment period.
• The participant (or their legally authorized representative) must provide informed written consent regarding the trial.
• The participant may consent to the secondary use of clinical information for future biomedical research. However, refusal to share clinical information for future research does not affect participation in the main trial.
• The participant must have adequate organ function as defined in the table below. Specimens must be collected within 28 days.
• \) Adequate bone marrow function defined as
• White Blood Cell (WBC)≥ 2,500/㎕
• Platelet (PLT)≥ 100,000/㎕
• Hemoglobin (H)≥ 8 g/dl (after correction in cases of simple iron-deficiency anemia) 2) Adequate renal function defined as
• Creatinine or Creatinine Clearance (Cr or CrCl) or Glomerular filtration rate (GFR) (GFR can also be used instead of Cr or CrCl)

You may not qualify if:

• Patients with non-epithelial ovarian cancer or borderline ovarian tumors.
• Patients with recurrent ovarian cancer who are not suitable for platinum-based chemotherapy.
• Patients over 80 years of age.
• Patients with a clinically assessed life expectancy of less than 3 months.
• Patients deemed unsuitable for secondary cytoreductive surgery due to clinical findings (e.g., severe adhesions, bowel obstruction, fistula, perforation, or other conditions making surgery infeasible).
• Patients with inadequate, cardiac, pulmonary, hepatic, renal, or bone marrow function for surgery.
• Patients with uncontrolled active infections.
• Patients diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or those exhibiting features suggestive of MDS/AML.
• Patients whose primary disease is an extra-abdominal condition that is expected to be a major cause of morbidity or mortality.
• Patients with active central nervous system metastasis or carcinomatous meningitis. Patients with a history of brain metastasis must be radiologically stable.
• Patients with infections requiring systemic treatment (parenteral administration of antibiotics for bacterial, antifungal, or antivirals).
• Patients with uncontrolled active tuberculosis (TB) within one month before treatment initiation.
• Patients with psychiatric disorders that may interfere with their ability to comply with the trial, including those diagnosed with mental illness or substance abuse disorders.
• Female patients who have not undergone a hysterectomy and have a positive urine pregnancy test within 14 days prior to study allocation. For women of childbearing potential, even if the screening urine pregnancy test is negative, additional pregnancy tests may be conducted at the discretion of the investigator at the time of surgery or chemotherapy initiation Pregnancy tests are not required for women who have undergone hysterectomy or are otherwise confirmed to be infertile.
• Patients who are currently breastfeeding.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are aware of their group assignment in this open-label randomized controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 12, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2033
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (1)