Standard of Care Therapy With Involved Field Radiation Th... | NCT03618706

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

NCT03618706

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Aug 7, 2018Actual

Enrollment

107Estimated

Phase

Phase 2

Conditions

Recurrent Ovarian Cancer

Interventions

Involved-field radiotherapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2018Actual

Primary Completion Date

May 9, 2023Estimated

Completion Date

May 9, 2023Estimated

First Submitted Date

Jul 9, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 7, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
involved-field RT + standard salvage treatment	Experimental	Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer	Radiation: Involved-field radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Involved-field radiotherapy	Radiation	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong Bae Kim, MD, PhD	Contact	82-2228-8095		ybkim3@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital	Recruiting	Seoul	Korea	120-752	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided