NCT03618706UnknownPhase 2
A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Yonsei University
- Enrollment
- 107
- Locations
- 2
- Primary Endpoint
- 2-year progression-free survival (PFS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
involved-field RT + standard salvage treatment
Experimental
Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer
Intervention: Involved-field radiotherapy (Radiation)
Outcomes
Primary Outcomes
2-year progression-free survival (PFS)
Time Frame: 2 years after radiotherapy
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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