Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma
NCT04678791 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286
Last updated 2020-12-22
Summary
To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.
Conditions
- Cervical Squamous Cell Carcinoma
Interventions
- DRUG
-
Nimotuzumab
Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
- DRUG
-
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
- RADIATION
-
External-beam radiation
Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
- RADIATION
-
Brachytherapy
Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 \~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.
Sponsors & Collaborators
-
Peking University Third Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-31
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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