Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer

A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer

This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).

Study Overview

• Status: Recruiting
• Conditions: Recurrent Ovarian Cancer
• Intervention / Treatment: Radiation: Involved-field radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 107
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yong Bae Kim, MD, PhD; Phone Number: 82-2228-8095; Email: ybkim3@yuhs.ac

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 120-752
      • Recruiting
      • Severance Hospital
      • Contact: YongBae Kim, MD; Phone Number: 82-10-6256-2592; Email: ybkim3@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically confirmed ovarian carcinoma
• Patients who received "standard treatment" for each stage as a primary treatment
• No. of recurrent lesions:

If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2

• Size of recurrent lesions ≤5 cm
• All recurrent lesions are available for involved-field radiotherapy
• Within 60 days before enrollment:
• Absolute neutrophil count ANC ≥ 500 / mm3
• Platelet ≥ 50,000 / mm3
• Hb ≥ 8.0 g / dl
• Good performance status (ECOG 0-1)

Exclusion Criteria:

• Brain metastasis
• Diffuse peritoneal carcinomatosis
• Malignant pleural effusion
• History of previous salvage radiotherapy for recurrent lesions
• History of other malignancy or severe/unstable medical condition

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: involved-field RT + standard salvage treatment; Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer	Radiation: Involved-field radiotherapy; After the diagnosis of recurrences, patients will receive involved-field radiotherapy (gross tumor volume + margin) with any radiation dose scheme (≥45 Gy Biological Equivalent dose) as physician's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year progression-free survival (PFS)	2 years after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control of recurred lesions		2 years after radiotherapy
Any other new recurrence events		2 years after radiotherapy
Radiotherapy-related complications		2 years after radiotherapy
Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)	It means the interval between the last date performing the previous chemotherapy (before the start of involved-field radiotherapy) and the first date performing the new regimen of chemotherapy (for the disease failures after the involve-field radiotherapy). We want to measure this interval because we want to check the capability of involved-field radiotherapy to delay the need for the new regimen of chemotherapy for the progressive diseases.	2 years after radiotherapy

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Anticipated): May 9, 2023
• Study Completion (Anticipated): May 9, 2023

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Recurrence; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 4-2018-0299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No