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The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial

NCT02135523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-05-17

No results posted yet for this study

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

Conditions

  • Ovarian Cancer (Epithelial)

Interventions

RADIATION

involved-field radiation therapy

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-06
Primary Completion
2018-01-08
Completion
2018-01-08

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135523 on ClinicalTrials.gov