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Trial Title:
Online Adaptive Radiotherapy for Cervical Cancer
NCT ID:
NCT06562166
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
adaptive radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Radiation
Intervention name:
online adaptive radiotherapy
Description:
Patients in ART group received daily online adaptive radiotherapy with a prescription
dose of 50.4Gy/28f.
Arm group label:
ART
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18-70 years old;
2. Pathologically confirmed diagnosis of cervical cancer and pathological type of
cervical squamous carcinoma;
3. 2018 FIGO Stage Ib3, II, 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06562166
