Ovarian Cancer (Epithelial) Clinical Trial
| Verified date | May 2018 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | January 8, 2018 |
| Est. primary completion date | January 8, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: 1. age> 19 years 2. ECOG performance status 0-1 3. pathologically confirmed malignant epithelial ovarian cancer 4. surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery 5. at least on of the following: consolidation therapy for grossly negative condition prior large tumor after surgery and adjuvant chemotherapy, residual tumor after adjuvant or salvage chemotherapy, local recurrent tumor after adjuvant or salvage chemotherapy, consolidation therapy after surgical removal of recurrent tumor Exclusion Criteria: 1. diffuse peritoneal seeding 2. brain or bone metastasis 3. prior invasive malignancy (except controlled skin cancer, carcinoma in situ of the cervix and early thyroid and gastric cancer) unless disease free for a minimum of 5 years prior to study entry 4. serious underlying medical disease 5. not providing informed consent |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Hospital | Seoul | Korea |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Two-year progression free survival(PFS) after involved-field radiation therapy | To determine whether involved-field radiation therapy will prove to be improved 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment. | Participants will be followed for 2 year after radiation therapy | |
| Secondary | overall survival | Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy | ||
| Secondary | chemotherapy-free survival | Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy | ||
| Secondary | in-field disease control | Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy | ||
| Secondary | serious adverse event | Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy |