Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-06-30

Brief Summary

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To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment

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Detailed Description

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Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.

Conditions

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Head and Neck Neoplasms AJCC Stage III/IV

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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Radiotherapy/Cisplatin(GroupA)

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)

Group Type ACTIVE_COMPARATOR

Chemoradiation

Intervention Type OTHER

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2

Radiotherapy/Cisplatin/Cetuximab(GroupB)

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)

Group Type EXPERIMENTAL

Chemoradiation plus Cetuximab

Intervention Type OTHER

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)

Interventions

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Chemoradiation plus Cetuximab

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)

Intervention Type OTHER

Chemoradiation

Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2

Intervention Type OTHER

Other Intervention Names

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Platinol Erbitux Platinol

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
* hypopharynx; age of 18 years or more
* adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
* kidneys (creatinine clearance ≥ 60ml/min
* heart (no arrythmias, no heart failure) and
* bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function
* ECOG performance status 0 or 1 and
* stage III or IVa to b with measurable lesions
* written informed consent