SABR-ROC

Design

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Study Schema
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Study objectives
Primary objectives
  • To evaluate whether the addition of SABR to standard treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer
Secondary objectives
  • To check whether it significantly affects quality of life (Health-related QoL)
  • To develop an AI-based predictive model for the treatment response of ovarian cancer subjects using image genomic analysis
  • To establish guidelines for ovarian cancer treatment guidelines
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Eligibility
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:
  • ㆍAbsolute neutrophil count (ANC) ≥ 500 / mm3
  • ㆍPlatelet ≥ 50,000 / mm3
  • ㆍHb ≥ 8.0 g / dl
  • ㆍ(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
  • ㆍUnstable angina or congestive heart failure requiring hospitalization within the last 6 months
  • ㆍDeep myocardial infarction within the last 6 months
  • ㆍAcute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
  • ㆍAt 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.
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
Multiple lesions within a defined anatomical site can be calculated as single lesion within single radiotherapy plan
  • Cervical lymph node, Rt & Lt
  • Central & peripheral lung, Rt & Lt
  • Pleura, Rt & Lt
  • Mediastinal lymph nodes
  • Liver lobe, Rt & Lt, & Perihepatic space
  • Spleen & Perisplenic space
  • Vertebral bone above & below 2 levels
  • Paraaortic, Paracaval & Pelvic lymph nodes
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SABR Dose & Fractionation
Number of Fractions Preferred Dose (Gy) Acceptable Doses (Gy) Major Deviation (Gy)
1 20 16 - 24 < 16 or > 24
3 30 24 - 36 < 24 or > 36
5 35 25 - 40 < 25 or > 40
10 40 35 – 45 < 35 or > 45
  • In patients allocated to arm 1 (standard of care), radiotherapy can be only applied for symptomatic lesions (bleeding, neurological deficit, pain, obstruction, dyspnea, etc.). Radiotherapy for asymptomatic lesions as well as the use of SABR regimens is not allowed.
  • In arm 1, radiotherapy dose delivered for symptom palliation should be lower than SABR regimens used in arm 2 based on the radiation biologically effective dose (linear quadratic model BED, alpha-beta ratio = 10 Gy), such as 30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, 8 Gy in 1 fraction, or other equivalent regimens.
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Remark
Existing standard salvage treatment is possible without any change in treatment pattern
  • Systemic therapy and tumor debulking surgery
  • Maintenance therapy
Radiation therapy
  • Not to replace the existing treatment, but to reduce the total burden of tumor by adding it
  • To investigate if it improves clinical outcomes and patients' quality of life
  • Applicability is recommended to be decided through close prior consultation between a gynecologic oncologist and a radiation oncologist.
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Example Cases (Pre-SABR-Post)