Cervical Cancer
Conditions
Keywords
cervical cancer, adaptive radiotherapy
Brief summary
This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.
Interventions
RADIATIONonline adaptive radiotherapy
Patients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f.
Sponsors
The First Affiliated Hospital of Jiangsu University
Zhongnan Hospital
Jingzhou First People's Hospital
The First Affiliated Hospital of Nanhua University
Tongji Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years old; 2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma; 3. 2018 FIGO Stage Ib3, II, IIIB and IIIC1 4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses) 5. ECOG score 0-2 6. Life expectancy greater than 6 months 7. Ability to remain lying down for more than 30 minutes 8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form 9. Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5\*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine <1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal 10. Must complete baseline assessments and investigations required before treatment before enrolment 11. be eligible for regular follow-up
Exclusion criteria
1. Have received radiotherapy or chemotherapy in the past 2. Have undergone radical surgery for cervical cancer 3. Have a previous history of malignant tumor 4. Pregnant or lactating women 5. Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute non-hematological toxicity | From the start of treatment until 3 months later | Acute non-hematologic toxicities include gastrointestinal and genitourinary toxicities, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment response | 3 months after completion of treatment | Treatment response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
Countries
China
Contacts
Primary ContactShuai Sun
Outcome results
None listed