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Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

NCT01516996 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-03-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Conditions

  • Oropharyngeal Cancer
  • Hypopharyngeal Cancer

Interventions

DRUG

docetaxel and cisplatin

* The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles. * CCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT

RADIATION

IMRT

IMRT is administered with chemotherapy from week 7 to week 13 * GTV（primary tumor）：68-70Gy/35\~38 F，once a day, 5 times per week * CTV（Clinical target）：56-66Gy/30\~36f，once a day, 5 times per week * GTV-ln（positive neck region）：66-70Gy/33\~36 F，once a day, 5 times per week * CTV-ln（negative neck region）：50-54Gy/28\~30F, once a day, 5 times

BIOLOGICAL

Nimotuzumab

Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    collaborator OTHER

  • The Second People's Hospital of Sichuan

    lead OTHER

Principal Investigators

  • Yi J Lang, M.D. · Radiotherapy department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-09-30
Completion
2018-03-31

Countries

  • China

Study Locations

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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 NCT01516996 on ClinicalTrials.gov