The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial
Primary Purpose
Ovarian Cancer (Epithelial)
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
involved-field radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer (Epithelial) focused on measuring ovarian cancer, involved-field radiation therapy, progression free survival
Eligibility Criteria
Inclusion Criteria:
- age> 19 years
- ECOG performance status 0-1
- pathologically confirmed malignant epithelial ovarian cancer
- surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery
- 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:
- diffuse peritoneal seeding
- brain or bone metastasis
- 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
- serious underlying medical disease
- not providing informed consent
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm: involved-field radiation therapy group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
overall survival
chemotherapy-free survival
in-field disease control
serious adverse event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02135523
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 6, 2014 (Actual)
Primary Completion Date
January 8, 2018 (Actual)
Study Completion Date
January 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Study period: 2014.04~2018.04
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.
Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer (Epithelial)
Keywords
ovarian cancer, involved-field radiation therapy, progression free survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm: involved-field radiation therapy group
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
involved-field radiation therapy
Intervention Description
Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment. Patients will be treated with 1.8-2.0Gy fraction, five times per week. It starts 2 weeks later of chemotherapy.
Primary Outcome Measure Information:
Title
Two-year progression free survival(PFS) after involved-field radiation therapy
Description
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.
Time Frame
Participants will be followed for 2 year after radiation therapy
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Title
chemotherapy-free survival
Time Frame
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Title
in-field disease control
Time Frame
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Title
serious adverse event
Time Frame
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age> 19 years
ECOG performance status 0-1
pathologically confirmed malignant epithelial ovarian cancer
surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery
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:
diffuse peritoneal seeding
brain or bone metastasis
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
serious underlying medical disease
not providing informed consent
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial
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