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

Recurrent Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03618706
• Other study ID #: 4-2018-0299
• Status: Recruiting
• Phase: Phase 2
• Start date: May 10, 2018
• Est. completion date: May 9, 2023

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: Yong Bae Kim, MD, PhD
• Phone: 82-2228-8095
• Email: ybkim3[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Recurrent Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year progression-free survival (PFS)		2 years after radiotherapy
Secondary	Local control of recurred lesions		2 years after radiotherapy
Secondary	Any other new recurrence events		2 years after radiotherapy
Secondary	Radiotherapy-related complications		2 years after radiotherapy
Secondary	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