Trials / Not Yet Recruiting
Not Yet RecruitingNCT04976478
Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (estimated)
- Sponsor
- Peking University Third Hospital · Academic / Other
- Sex
- Female
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma
Detailed description
This is a perspective, multi-center, open-label and single arm study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nimotuzumab | Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks. |
| RADIATION | EBRT combined with brachytherapy | IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8\~2.0Gy/f, 25\~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60\~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy. Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80\~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks. |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2021-07-26
- Last updated
- 2021-07-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04976478. Inclusion in this directory is not an endorsement.