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Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

P

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

Trial contacts and locations

1

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Central trial contact

Heming Lu, MS

Data sourced from clinicaltrials.gov

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