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

May 14, 2018 updated by: Yonsei University
  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm: involved-field radiation therapy group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two-year progression free survival(PFS) after involved-field radiation therapy
Time Frame: Participants will be followed for 2 year after 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 Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
chemotherapy-free survival
Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
in-field disease control
Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
serious adverse event
Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy
Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2014

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

January 8, 2018

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0896

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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