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Comparison of Neoadjuvant Chemotherapy Combined with Surgery versus Adjuvant Chemotherapy after Surgery in the Treatment of Ovarian Cancer

Investigation and comparison of one-year survival rate and one-year disease-free time of combined treatment of neoadjuvant chemotherapy and surgery compared to adjuvant chemotherapy after surgery in patients with ovarian cancer referred to teaching hospitals of Qom province

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250902067090N1
Enrollment
82
Registered
2025-09-10
Start date
2025-09-06
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer. Malignant neoplasm of ovary

Interventions

Intervention 1: Intervention group: Patients receiving combined neoadjuvant chemotherapy and surgery. Patients in Group 1 will receive neoadjuvant chemotherapy with cisplatin 75 mg/m² and docetaxel 75

Sponsors

Ghoum University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

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

MeasureTime 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

Public ContactAbbas Eshraghi

Ghoum University of Medical Sciences

ae845@yahoo.com+98 25 3612 2000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026