Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer

Официальное название

Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer: A Phase II Randomized Controlled Trial

Обзор

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

Подробное описание

\[Primary Objective\] To compare the progression-free survival (PFS) between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy.

\[Secondary Objectives\]

1. To compare the overall survival (OS) and cancer-specific survival (CSS) between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 2. To evaluate the adverse events between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 3. To assess the quality of life (QoL) between the CRS group and the control group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 4. To investigate the prognostic role of the CA-125 KELIM model in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy. 5. To perform a cost-effectiveness analysis of the CRS group in patients with recurrent epithelial ovarian cancer who have undergone chemotherapy.

Вмешательства

• Процедура Secondary Cytoreductive Surgery
  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.

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: From randomization to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 5 years]

Вторичные конечные точки (8)

• Overall survival [Срок оценки: From randomization to the date of death from any cause, assessed up to 5 years]
• Cancer specific survival [Срок оценки: From date of randomization until the date of death due to ovarian cancer, assessed up to 5 years]
• Adverse Event [Срок оценки: 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) [Срок оценки: Over the 5 year surveillance period]
• Health-related quality of life (EORTC-QLQ-OV28) [Срок оценки: Over the 5 year surveillance period]
• Health-related quality of life (EQ-5D-5L) [Срок оценки: Over the 5 year surveillance period]
• CA-125 KELIM Model [Срок оценки: Over the 5 year surveillance period]
• Economic and cost evaluation [Срок оценки: At the time of completion of 5-year surveilance period]

Критерии участия

\[Inclusion Criteria\]

• 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.

1\) 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)

• Creatinine ≤ 1.5 mg/dL or within 1.5 times the upper limit of normal (ULN)
• CrCl ≥ 30 mL/min or GFR-EPI ≥ 30 mL/min/1.73m² 3) Adequate liver function defined as
• Total Bilirubin≤ 1.5 x ULN
• AST (SGOT) and ALT (SGPT)≤ 2.5 x ULN (for patients with liver metastasis, ≤ 5.0 x ULN) 4) No Significant dysfunction in Heart, Lungs, etc.

• No abnormalities in preoperative pulmonary function tests, electrocardiograms (ECG), or chest X-rays.
• For patients with a history of cardiac or pulmonary diseases, a collaborative evaluation with cardiology or pulmonology must confirm that surgery is feasible.

ALT(SGPT) = alanine aminotransferase (serum glutamic pyruvic transaminase) AST(SGOT) = aspartate aminotransferase (serum glutamic oxaloacetic transaminase) GFR = glomerular filtration rate; ULN = upper limit of normal

\[Exclusion Criteria\]

• 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.
• Patients with a history of allogeneic tissue/solid organ transplantation, bone marrow transplantation, or dual umbilical cord blood transplantation.
• Patients who, in the judgment of the principal investigator, are unlikely to comply with the trial procedures, restrictions, and requirements.
• Patients currently enrolled in another clinical trial and receiving an investigational drugs or medical device, or those who have used any investigational drugs or device within 3 weeks prior to the first administration of the study treatment.
• Patients who have entered the follow-up phase of a clinical trial may participate in this study only if at least 3 weeks have passed since their last use of an investigational drug or device.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• National Cancer Center, Korea — Goyang-si

Идентификаторы

NCT: NCT07171528 · NCC2025-0092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗