Status:
NOT_YET_RECRUITING
A Clinical Study of Pelvic Concurrent Chemoradiotherapy Combined with CT-guided Intracavitary Brachytherapy with Adaptive Simultaneous Dose Escalation for Locally Advanced Cervical Cancer
Lead Sponsor:
Peking University Third Hospital
Conditions:
Locally Advanced Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiotherapy with external beam radiotherapy (EBRT) and Brachytherapy (BT). overall treatment time (OTT) ...
Eligibility Criteria
Inclusion
- Sign the informed consent;
- Age :18 to 75 years old;
- Histologically or cytologically confirmed cervical cancer;
- According to the International Federation of Gynecology and Obstetrics (FIGO 2018) stage IB3, IIA2, IIB, III, IV (local advanced), and had not received treatment before enrollment;
- Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- ECOG physical performance score 0-2;
- Expected survival time \>= 3 months;
- LVEF \>= 55%;
- Bone marrow function: neutrophil \>= 1.5×109/L, platelet ≥ 100×109/L, white blood cell 4.0-10.0×109/L, hemoglobin \>= 90 g/L;
- Liver and kidney function: serum creatinine \<= 1.5 times upper limit of normal; AST and ALT≤2.5 times upper limit of normal (ULN) or \<= 5 times ULN in the presence of liver metastasis; Total bilirubin \<=1.5 times upper limit of normal, or \<= 2.5 times upper limit of normal if the patient has Gilbert's syndrome;
- Subjects of childbearing age must agree to use effective contraception during the trial, and women of childbearing age must have a negative serum or urine pregnancy test;
- Non-lactating patients;
Exclusion
- Patients with prior abdominal or pelvic radiotherapy;
- being mentally ill and unable to cooperate with treatment;
- Serious uncontrolled medical diseases, such as serious internal medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- Unable to tolerate cisplatin chemotherapy;
- receiving other experimental drugs or participating in clinical trials for other anticancer treatment purposes within 30 days before the first radiotherapy;
- Severe infection within 4 weeks before study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia;
- Human immunodeficiency virus (HIV) -positive persons;
- HBsAg positive and HBV-DNA titer \>= 1×10\^3 IU/mL; Participants were eligible for inclusion if they were HBsAg positive and had a peripheral blood HBV-DNA level of \< 1×10\^3 IU/mL, and if the investigator considered the participant to be in a stable phase of chronic hepatitis B without increasing the risk to the participant.
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive;
- Patients judged by the investigator to be ineligible for the study.
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06882473
Start Date
March 15 2025
End Date
March 15 2027
Last Update
March 18 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191