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

Study Overview
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Brief Summary
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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).

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

Conditions
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Recurrent Ovarian Cancer

Intervention / Treatment
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* Radiation: Involved-field radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: involved-field RT + standard salvage treatment<br>Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer | Radiation: Involved-field radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |