Clinical trial NCT02135523: The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer (Epithelial)
Keywords: ovarian cancer
involved-field radiation therapy
progression free survival
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Two-year progression free survival(PFS) after involved-field radiation therapy
timeFrame: Participants will be followed for 2 year after radiation therapy
Secondary outcomes:
measure: overall survival
timeFrame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
measure: chemotherapy-free survival
timeFrame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
measure: in-field disease control
timeFrame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
measure: serious adverse event
timeFrame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Korea
Study officials:
References: