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Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT ID: NCT00623558

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-08-31

Brief Summary

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The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.

Detailed Description

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Conditions

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Head and Neck Neoplasm

Keywords

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head and neck neoplasm cetuximab docetaxel cisplatin radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Docetaxel+CDDP

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Cisplatin

Intervention Type DRUG

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

2

Docetaxel+CDDP+Cetuximab

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks

Docetaxel

Intervention Type DRUG

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Cisplatin

Intervention Type DRUG

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Interventions

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Cetuximab

400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks

Intervention Type DRUG

Docetaxel

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Intervention Type DRUG

Cisplatin

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
* ECOG performance status 0-1
* Age 18 or older than 18 years
* Measurable disease by RECIST criteria
* Having signed informed consent
* ALT and AST\<2.5 times ULN
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Bilirubin level \< 1.5mg/dL
* Serum creatinine \<1.5 times ULN
* WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl

Exclusion Criteria

* Previous cytotoxic chemotherapy for HNSCC
* Radiotherapy for targeted lesions within six months
* Previous EGFR pathway-targeting therapy
* Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
* Distant metastatic disease
* Heart failure, coronary artery disease, myocardial infarction within the last 6 months
* Known allergy to any study treatment
* Pregnancy or lactation period
* Any investigational agent within the past 28 days
* Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
* Legal incapacity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Center for Solid Tumor, Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dae Seog Heo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dae Seog Heo, Prof.

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center for Solid Tumors, Korea

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.

Reference Type DERIVED
PMID: 26304911 (View on PubMed)

Other Identifiers

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CRCST-L0002

Identifier Type: -

Identifier Source: org_study_id