Ovarian cancer. Malignant neoplasm of ovary
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with epithelial ovarian cancer, stage II and IIIA and B (according to the FIGO system), referred to Forqani and Shahid Beheshti Hospitals in Qom Patients eligible for surgery and chemotherapy
Exclusion criteria
Exclusion criteria: Patients with contraindications to chemotherapy or surgery Patients with other underlying diseases such as malignancies, etc Patients with metastasis to other organs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome 1:One-year overall survival of patients: The survival status (alive or deceased) of patients one year after the initiation of the treatment intervention, assessed via in-person and telephone follow-up. This variable serves as the main measure to evaluate the effectiveness of the treatment interventions (neoadjuvant chemotherapy + surgery vs. surgery + adjuvant chemotherapy), and the sample size was calculated based on the expected difference in one-year survival rates./ Primary Outcome 2:One-year disease-free survival: The duration during which patients remain free of cancer recurrence after starting the treatment intervention, assessed through periodic evaluations including abdominal and pelvic ultrasound, MRI, and CA125 testing. This variable is used to evaluate the effect of the interventions on disease control during the one-year follow-up period./ Primary Outcome 3:Surgical success: The absence of residual tumor lesions greater than 1 cm in diameter following cytoreductive surgery, determined based on surgical reports and pathological findings. This variable is used to assess the quality and effectiveness of the surgical intervention as part of the overall treatment of patients. Timepoint: Patients in both groups will be treated by a gynecologic surgeon and a specialist oncologist and will be followed up for one year. During this period, abdominal and pelvic ultrasound, MRI, and CA125 tests will be repeated every three months. Method of measurement: The outcome variables include one-year overall survival and one-year disease-free survival. These variables will be measured through in-person patient follow-ups, laboratory assessments including serum CA125, and imaging evaluations including abdominal and pelvic ultrasound and magnetic resonance imaging. Patient information will be collected using a standardized checklist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Ghoum University of Medical Sciences