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

Phase 2

• Conditions: Recurrent Ovarian Cancer
• Interventions: Radiation: Involved-field radiotherapy

• Registration Number: NCT03618706
• Lead Sponsor: Yonsei University

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 available

Study Timeline

• Study Start: 2018-05-10
• Status Verified: 2018-07
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-07
• Last Update Posted: 2018-08-07
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 107

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
involved-field RT + standard salvage treatment	Involved-field radiotherapy	Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer

Primary Outcome Measures

Name	Time	Method
2-year progression-free survival (PFS)	2 years after radiotherapy

Secondary Outcome Measures

Name	Time	Method
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)	2 years after radiotherapy	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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of