Prospective Multi-institutional Phase III Trial of Salvage Systemic Therapy with or without Stereotactic Ablative Radiation Therapy for Recurrent Ovarian Cancer
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 270
Inclusion Criteria:
•Pathologically confirmed epithelial ovarian cancer
•Should have completed standard treatment for the primary tumor initially. (In the case of advanced ovarian cancer, maximal debulking operation and adjuvant platinum-based chemotherapy are performed according to the stage)
•Number if recurred site allowed; within 10
•Maximum diameter of each metastasis site of gross tumor = 5 cm
•Age = 19 year old
•Sufficient bone marrow function on tests performed within 60 days prior to study enrollment, including:
?Absolute neutrophil count (ANC) = 500 / mm3
?Platelet = 50,000 / mm3
?Hb = 8.0 g / dl (Treatments such as blood transfusions to maintain hemoglobin count are permitted)
•Zubrod daily living performance = 2 within 60 days prior to study enrollment
•Subjects must submit research-related informed consent prior to participation in the study
Exclusion Criteria:
•Brain metastasis
•Diffuse peritoneal carcinomatosis
•Exudative, hematological, or cytologically proven malignant exudate (Malignant pleural effusion)
•If previously treated with radiation therapy to metastases
•When targeting is difficult because the boundary of the metastasis site is not clear
•Coexisting or previous invasive cancer (excluding Thyroid cancer, Cervix CIS, basal cell carcinoma of skin, early gastric cancer) has not been disease-free for more than 3 years.
•Pregnancy
•Serious comorbidities defined as below
?Unstable angina or congestive heart failure requiring hospitalization within the last 6 months
?Deep myocardial infarction within the last 6 months
?Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
?At the time of enrollment, exacerbation of chronic obstructive pulmonary disease or other respiratory disease that requires hospitalization or makes it difficult to proceed with treatment in this study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Control of existing metastases;occurrence of new metastases;Adverse Event;Chemotherapy-free interval ;Patient-Reported Outcome;Health-related quality of life and patient-reported outcome using EORTC and CTSQ questionaires;Discovery of treatment-refractory molecular subtypes through next-generation sequencing, and development of predictive models using artificial intelligence-based radiomix;Analysis of clinically meaningful descriptive variables described in the protocol