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โ† Trials
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Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian Cancer

RecruitingNAAges 19 Years - anyFemaleYonsei University
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In plain words

What the trial is, and whether it could suit you

Rationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. The use of target and immune agents have demonstrated to improve survival. However, long-term maintenance of systemic therapy is often difficult because recurrent tumors do not respond uniformly to systemic therapy. In the 1980\~1990s, whole abdomen irradiation had been tried and faded out owing to many side effects with the introduction of taxane. Efforts have been made to find the role of salvage radiation therapy (RT) in recurrent ovarian cancer. Involved field radiotherapy (IFRT) emerged to cover the gross tumor plus regional microscopic disease in addition to salvage chemotherapy. It showed high local control, p

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๐Ÿ“‹ Eligibility rules (as published)
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 of metastases allowed: โ‰ค 10 (Adjacent lesions can be counted as a single lesion if possible to be included in a single radiotherapy treatment plan) (left cervical lymph node, right cervical lymph node, center of the left lung, periphery of the left lung, left pleura, center of the right lung, periphery of the right lung, right pleura, mediastinal lymph node, left lobe of the liver, right lobe of the liver, perihepatic space, spleen, perisplenic space, within 2 vertebrae above or below based on the spine with the lesion, abdominal cavity, pelvic cavity, paraaortic lymph node, and pelvic lymph nodes) * Maximum diameter of each metastasis site of gross tumor โ‰ค 5 cm * Age โ‰ฅ 19 year old * Sufficient bone marrow function on tests performed within 60 days prior to study enrollment, including: * Absolute neutrophil count (ANC) โ‰ฅ 500 / mm3 * Platelet โ‰ฅ 50,000 / mm3 * Hb โ‰ฅ 8.0 g / dl (Treatments such as blood transfusions to maintain hemoglobin count are permitted) * Zubrod daily living performance โ‰ค 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.
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What it tests

  • Standard salvage therapy
  • Standard salvage therapy + SABR
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Where

1 site
Yonsei University Health System, Severance Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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