Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

People's Hospital of Guangxi

Status and phase: Unknown; Phase 2

Conditions: Locally Advanced Cervical Cancer

Treatments: Other: Nimotuzumab+chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01938105

WJPMF-2013-428-2081

Details and patient eligibility

About

The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically proven squamous cell cervical cancer
• Stages IB2-IIIB according to FIGO Staging System
• Age:18-75
• ECOG<2
• Normal bone marrow function
• Initial assessed and considered not candidates for operation
• Signed study-specific consent form

Exclusion criteria

• Pregnant or lactating women
• Patients with other malignancies
• Patients who received radiotherapy or chemotherapy previously
• Presence of uncontrolled life-threatening illness
• Allergy to platinum or monoclonal antibody

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Nimotuzumab+chemoradiotherapy

Experimental group

Treatment:

Other: Nimotuzumab+chemoradiotherapy