Gynecological Tumors
Conditions
Interventions
Part Two: Experimental Group:Active Bone Marrow Sparing
Part Two: Control Group:Conventional Radiotherapy
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age:18-75years; 2.Histologically confirmed cervical or uterine corpus carcinoma (including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, undifferentiated carcinoma, etc.), with clinical StageI-IVA (FIGO 2018 staging). Measurable Disease: At least one measurable lesion per RECIST 1.1 criteria; 3.According to the RECIST 1.1 criteria, there must be at least one measurable lesion; 4.No severe hematopoietic dysfunction, abnormalities in heart, lung, liver, or kidney function, or immunodeficiency. Laboratory test results must meet the following criteria: Hemoglobin >=90 g/L Absolute neutrophil count >=2×10^9/L or white blood cell count >=4.0×10^9/L Platelet count >=100×10^9/L Aspartate aminotransferase (AST) =3 months; 7.Pregnancy Test: Negative serum/urine HCG within72hours prior to enrollment for women of childbearing potential (WOCBP). 8.Without intrauterine device (IUD); 9.Women of childbearing potential must agree to use medically approved contraceptive methods throughout the study period. 10.Informed Consent: Willing and able to provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Prior pelvic radiotherapy, targeted therapy, or immunotherapy for cancer; 2.Bilateral ureteral obstruction with failure of ureteral stenting or nephrostomy; 3.Pregnancy or lactation; 4.Rectovaginal/vesicovaginal fistula, uncontrolled vaginal bleeding, or high fistula risk; 5.HIV infection; 6.Active HBV infection (HBV DNA above detection limit) or HCV infection (HCV RNA above detection limit); 7.Severe comorbidities compromising treatment safety, including: Active infections requiring systemic therapy; Decompensated heart failure (NYHA Class III/IV within 3 months); Unstable angina or acute myocardial infarction. 8.History of other malignancies (except cured basal cell carcinoma; 9.Crohn’s disease or ulcerative colitis; 10.Current participation in other trials or withdrawal from trials within 4 weeks; 11.Contraindications to cisplatin; 12.Neurological/psychiatric disorders impairing cognition; 13.Lesions deemed unsuitable for intracavitary radiotherapy by investigators; 14.Other investigator-determined exclusions;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;No local recurrence of the disease;Disease-free survival;Adverse reaction; | — |
Countries
China
Contacts
Public ContactYajie Liu
Peking University Shenzhen Hospital
Outcome results
None listed