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

NCT03469531 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-13

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • junguo bu, doctor · Zhujiang Hospital

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
2018-03-20
Primary Completion
2021-03-10
Completion
2021-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469531 on ClinicalTrials.gov