Ovarian Cancer Clinical Trial
Official title:
Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer
In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 1, 2024 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18; 2. Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) 3. Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions =3; 4. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency 5. Cooperative Oncology Group-Status (ECOG Status) score 0-2; 6. Expected survival =3 months; 7. Feasible abdomen and pelvic cavity MRI/CT; 8. Good compliance, signed informed consent voluntarily. Exclusion Criteria: 1. Previous radiotherapy at the target lesion site; 2. History of active inflammatory bowel disease or severe stomach and duodenal ulcers; 3. Human immunodeficiency virus (HIV) infected persons; 4. active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit); 5. suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication: 6. patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin); 7. neurological or mental disorders that affect cognitive ability; 8. Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy; 9. those who cannot follow up regularly as prescribed by the doctor; 10. Other reasons not suitable for participating in this study as judged by the researcher. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Health Science Center of Xi'an Jiaotong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Control ( LC ) | LC will be measured from the start date of treatment until the date of progressive of the target lesion | 6 months | |
Secondary | Progression-free Survival ( PFS ) | PFS is defined as the time from first day of treatment until the first date of either objective disease progression or death due to any cause | 24 months | |
Secondary | Overall Survival ( OS ) | OS is defined as the time from first day of treatment until the date of death due to any cause or the deadline for the study | 24 months | |
Secondary | Rate of Radiation-related Adverse Reactions | Rate of acute and late adverse reactions associated with radiotherapy | 24 months |
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