cervical cancer
Conditions
Interventions
treatment group:Brachytherapy and CT-guided online adaptive external beam pelvic radiotherapy are delivered on the same day
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent; 2. Age :18 to 75 years old; 3. Histologically or cytologically confirmed cervical cancer; 4. According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment; 5. Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 6. ECOG physical performance score 0-2; 7. Expected survival time >= 3 months; 8. LVEF >= 55%; 9. Bone marrow function: neutrophil >= 1.5×109/L, platelet = 100×109/L, white blood cell 4.0-10.0×109/L, hemoglobin >= 90 g/L; 10. Liver and kidney function: serum creatinine <= 1.5 times upper limit of normal; AST and ALT=2.5 times upper limit of normal (ULN) or <= 5 times ULN in the presence of liver metastasis; Total bilirubin <=1.5 times upper limit of normal, or <= 2.5 times upper limit of normal if the patient has Gilbert's syndrome; 11. Subjects of childbearing age must agree to use effective contraception during the trial, and women of childbearing age must have a negative serum or urine pregnancy test; 12. Non-lactating patients;
Exclusion criteria
Exclusion criteria: 1. Patients with prior abdominal or pelvic radiotherapy; 2. being mentally ill and unable to cooperate with treatment; 3. Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 4. Unable to tolerate cisplatin chemotherapy; 5. receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy; 6. Severe infection within 4 weeks before study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia; 7. Human immunodeficiency virus (HIV) -positive persons; 8. HBsAg positive and HBV-DNA titer >= 1×10^3 IU/mL; Participants were eligible for inclusion if they were HBsAg positive and had a peripheral blood HBV-DNA level of < 1×10^3 IU/mL, and if the investigator considered the participant to be in a stable phase of chronic hepatitis B without increasing the risk to the participant. 9. Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive; 10. Patients judged by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the nature of adverse events;the frequency of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate ;tumor control rate ;local progression-free survival time ; | — |
Countries
China
Contacts
Public ContactPing Jiang
Peking University Third Hospital
Outcome results
None listed