Cervical cancer
Conditions
Interventions
Intervention group:CBCT-guided daily online adaptive radiotherapy
Control group:Daily Image Guided Radiation Therapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: a, cervical squamous cell carcinoma, adenocarcinoma, or adeno-squamous cell carcinoma. b. Stage I-IVA (according to FIGO 2018 edition). c. No evidence of distant metastasis (M0). d. Karnofsky scale (KPS) > 70. e. Normal bone marrow function: white blood cell count > 4×10^9/L, hemoglobin > 80g/L (or moderate to severe anemia can be corrected by blood transfusion treatment) and platelet count > 100×10^9/L. f. Normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) 60 ml/min. h. Age 18-80 years old. i. Have indications of radical or postoperative adjuvant IMRT radiotherapy. j. Patients are fulled informed of the basic contents of the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: a. Have organic problems in the lumbar spine or other parts, and cannot maintain a fixed position for more than 30 minutes. b. With organic bladder diseases, such as vesico-vaginal fistula, bladder contracture and other bladder function abnormalities, unable to fill the bladder. c. With severe mental illness, cognitive impairment and thinking impairment, or incontinence. d. With chronic inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. e. With aplastic anemia, myelodysplastic syndrome, idiopathic thrombocytopenic purpura and other myelopoietic disorders. f. Treatment is palliative. g. History of malignant neoplasms in the last 5 years, except for well-treated basal cell or squamous cell carcinoma and carcinoma in situ of the cervix. h. Pregnancy or breastfeeding (pregnancy tests should be considered for women of childbearing age; Effective contraception should be emphasized during treatment). i. Previously received pelvic and abdominal radiation. j. With other serious disorders that may pose a greater risk or affect compliance with the test. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), etc. k. Severe hemorrhoids or other diseases deemed unsuitable for inclusion by the investigators. l. Allergies to any of the drugs in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients reported moderate to severe radiation related acute gastrointestinal reaction (acute gastrointestinal, GI) and acute urinary reaction;Complete remission (CR) [Time Frame: 3-month post radiotherapy]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, (DFS) [Time Frame: 2-year];overall survival (OS) [Time Frame: 2-year];Loco-regionally relapse-free survival (LRRFS) [Time Frame: 2-year];Distant metastasis-free survival (DMFS) [Time Frame: 2-year];Oncologist evaluated grade 2-5 acute gastrointestinal, urinary reaction;Moderate to severe acute skin reaction;Chronic grade 2-5 gastrointestinal, urinary, and skin reactions;Quality of life; | — |
Countries
China
Contacts
Public ContactYi Ouyang
Sun Yat-sen University Cancer Center
Outcome results
None listed