Ovarian Cancer (Epithelial) Clinical Trial
1. Title: The efficacy of involved-field radiation therapy for residual or locoregionally
recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional
phase 2 clinical trial
2. Study period: 2014.04~2018.04
3. Objective: To determine whether involved-field radiation therapy will prove to be
improve 2-year progression free survival for residual or locoregionally recurrent
epithelial ovarian cancer patients after definitive treatment.
4. Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)
5. Planned number of patients
- YUHS database have 149 FIGO stage III patients treated with debulking surgery and
adjuvant platinum-based chemotherapy 2.
- Of these patients, 90 patients experienced locoregional failures, and then the
investigators selected 44 patients who could be treated effectively with IFRT based
on MDACC suggestion.
- Median interval to failure was 9 months in these patients
- Hypothesis; IFRT reduces 44% hazard of progression compared with patients
without IFRT
- Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power
= 0.80 Null progression-free median survival = 9 mo Alt progression-free
median survival = 16 mo Calculated sample number = total 27 patients Drop rate
= 10% • Total sample number = 30 patients Estimated Enrollment : 30
participants
Drop rate = 10%
- Total sample number = 70 patients 6. Radiation therapy: Participants will receive
involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy with
1.8-2.0 Gy fraction, five times per week for residual or locoregionally recurrent
epithelial ovarian cancer after definitive treatment
- Target volume
- directed to gross disease plus a high-risk clinical target volume (CTV) that
included the postoperative bed or the prechemotherapy extent of disease with a 1-
to 1.5-cm margin, excluding uninvolved clinical structures
- Additional CTVs were designated according to the risks of microscopic disease
spread, proximity to critical structures, and other risk factors for complications.
- Nodal CTVs included grossly involved lymph node sites, extending to cover adjacent
uninvolved regions.
- Modality; 3-dimensional conformal RT including electron, intensity-modulated RT, proton
beam RT 7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24
month after radiation therapy 8. Key words: ovarian cancer, involved-field radiation
therapy, progression free survival
n/a