NCT06882473Not 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
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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) has been found to be an important predictor of treatment response. Some studies have shown that the acceleration of tumor cell regeneration during the extension of radiotherapy leads to poor local control. Prolonging the overall treatment time of cervical cancer radiotherapy for more than 8 weeks leads to an increase in pelvic local control failure. Therefore, shortening OTT has great potential benefits from both clinical efficacy and social benefits. Shortening OTT in radical cervical cancer radiotherapy includes hypofractionated EBRT and shortening the interval between BT and EBRT. However, further shortening OTT may lead to an increase in acute and late toxicity. Adaptive radiotherapy (ART) strategies systematically monitor variations in target and neighbouring structures to inform treatment-plan modification during radiotherapy. The application of image-guided adaptive brachytherapy (IGABT) has clearly demonstrated the advantages of this approach in the treatment of cervical cancer. Previous studies have shown that the implementation of IGABT can achieve personalized treatment, dose increase, improve clinical efficacy, reduce normal tissue toxicity and side effects, and strengthen international standardized quality control. In this study, online adaptive pelvic EBRT combined with IGABT based on uRT-linac was performed under online CT guidance. The aim of this study is to evaluate the safety and efficacy of pelvic concurrent chemoradiotherapy combined with CT-guided intracavitary brachytherapy with adaptive simultaneous dose escalation in locally advanced cervical cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 7 Feb 2025
- Start date
- 15 Mar 2025
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT06882473
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 15 Mar 2025 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior abdominal or pelvic radiotherapy;
- 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;
Other illness
- 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.;
- Human immunodeficiency virus (HIV) -positive persons;
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive and HCV RNA test positive;
Lab values
- 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.
Other
- being mentally ill and unable to cooperate with treatment;
- Patients judged by the investigator to be ineligible for the study.
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.