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

Primary Purpose

Recurrent Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Involved-field radiotherapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

involved-field RT + standard salvage treatment

Arm Description

Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer

Outcomes

Primary Outcome Measures

2-year progression-free survival (PFS)

Secondary Outcome Measures

Local control of recurred lesions
Any other new recurrence events
Radiotherapy-related complications
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.

Full Information

First Posted
July 9, 2018
Last Updated
August 1, 2018
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03618706
Brief Title
Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Official Title
A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
May 9, 2023 (Anticipated)
Study Completion Date
May 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
involved-field RT + standard salvage treatment
Arm Type
Experimental
Arm Description
Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer
Intervention Type
Radiation
Intervention Name(s)
Involved-field radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
2-year progression-free survival (PFS)
Time Frame
2 years after radiotherapy
Secondary Outcome Measure Information:
Title
Local control of recurred lesions
Time Frame
2 years after radiotherapy
Title
Any other new recurrence events
Time Frame
2 years after radiotherapy
Title
Radiotherapy-related complications
Time Frame
2 years after radiotherapy
Title
Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)
Description
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.
Time Frame
2 years after radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Bae Kim, MD, PhD
Phone
82-2228-8095
Email
ybkim3@yuhs.ac
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YongBae Kim, MD
Phone
82-10-6256-2592
Email
ybkim3@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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

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