Treatment for recurrent ovarian cancer using radiation therapy and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of salvage systemic therapy with or without stereotactic ablative radiotherapy (SABR) for patients with recurrent epithelial ovarian cancer. The study aims to evaluate the potential benefits of combining standard salvage therapy with SABR to improve local control of the disease and provide a chemotherapy holiday. Patients will undergo a series of evaluations, including imaging and tumor marker assessments, to monitor treatment response and side effects over a period of 36 months. The trial includes specific eligibility criteria to ensure that participants have pathologically confirmed ovarian cancer and have completed initial standard treatments.

Why it matters

Who can join: the full rules

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: ≤ 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 ≤ 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.

Where it's running

• Yonsei University Health System, Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Yong Bae Kim
• Email: ybkim3@yuhs.ac
• Phone: 82-2-2228-8095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.