NCT03469531

Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

Detailed description

This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.

Conditions

• Neoplasms
• Cervical Adenosquamous Cell Carcinoma
• Cervical Squamous Cell Carcinoma in Situ
• Stage IB Cervical Cancer
• Stage IIA Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Cervical Cancer
• Stage IVA Cervical Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
DRUG	Cisplatin	Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
RADIATION	external-beam radiation	Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
RADIATION	brachytherapy	high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy

Timeline

• Start date: 2018-03-20
• Primary completion: 2021-03-10
• Completion: 2021-12-30
• First posted: 2018-03-19
• Last updated: 2018-08-13

Locations

1 site across 1 country: China