Cervical cancer
Conditions
Interventions
Experimental Group:Brachytherapy at close range uses ICBT IMRT technology
Control group:Brachytherapy is performed using ICBT technology
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological histological examination confirmed diagnosis of stage IIB, IIIA, IIIB, IIIC, IVa (FIGO 2018 staging) cervical squamous cell carcinoma; 2. Age >= 18 years and = 1.5×10^9/L; (2) Hemoglobin (HB) >= 8g/dL; (3) Platelets (PLT) >= 50×10^9/L; (4) Serum albumin (ALB) >= 2.8g/dL; (5) White blood cells (WBC) >= 4.0×10^9/L; 9. Biochemical tests must meet the following criteria: (1) Total bilirubin (TBIL) = 50ml/min (Cockcroft-Gault formula); (4) Blood urea nitrogen (BUN) within normal range; (5) Normal thyroid function; 10. Expected survival > 6 months; 11. For women of childbearing age, a urine or serum pregnancy test must be conducted within 3 days prior to the first administration of the study drug (day 1 of cycle 1), and the result must be negative. If the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women who are not of childbearing age are defined as postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; 12. The patient voluntarily participates in this study and signs the informed consent form (ICF), showing good compliance and cooperation for follow-up.
Exclusion criteria
Exclusion criteria: Cancer-specific exclusion criteria: 1. Diagnosis of any malignant disease other than cervical cancer within 5 years prior to initial treatment (excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ); 2. Stage I, IIA, or IVb cervical cancer (FIGO 2018 staging) confirmed by gynecological examination, CT, or MRI assessments during the screening period, or by prior imaging assessments; 3. Pathological types of cervical cancer such as: adenocarcinoma, small cell carcinoma, and other rare pathological types; 4. Currently participating in interventional clinical research treatment, or received other investigational drugs or treatment with investigational devices within 4 weeks prior to the first administration; 5. Undergoing major surgical treatment within 4 weeks before starting treatment (except surgeries for biopsy purposes) or expected to undergo major surgery during the study; 6. Severe non-healing wounds, ulcers, or fractures; 7. Clinically uncontrollable pleural effusion/ascites (patients who do not need drainage of fluid or have had fluid drainage stopped for 3 days without significant increase in fluid can be included); 8. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 10. Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number exceeding the normal upper limit of the testing laboratory in the study center); Note: Subjects with hepatitis B meeting the following criteria may also be included: HBV viral load = 2; (3) Any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; (4) Poorly controlled blood pressure (systolic >140 mmHg, diastolic >90 mmHg); (5) Active pulmonary tuberculosis; (6) Presence of active or uncontrolled infections requiring systemic treatment; (7) Presence of clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; (8) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (9) Poor control of diabetes (fasting blood glucose (FBG) >10mmol/L); (10) Urinalysis indicating urine protein >= and confirmed 24-hour urine protein quantitative >1.0 g; (11) Presence of mental disorders that prevent cooperation with treatment; 13. The investiga
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival,DFS;Local recurrence-free survival,LRFS;Overall survival, OS;Adverse events (AEs) assessed by RTOG/EORTC acute (early) and chronic (late) radiation injury grading standards;Quality of Life Scale Scores Patient-reported outcomes of health-related quality of life (HRQoL) defined by the EORTC QLQ-C30; | — |
Countries
China
Contacts
Public ContactShun Lu
Sichuan Cancer Hospital
Outcome results
None listed