Recurrent Ovarian Cancer
Conditions
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).
Interventions
RADIATIONInvolved-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.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival (PFS) | 2 years after radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactYong Bae Kim, MD, PhD
Outcome results
None listed