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

Theagenio Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: AJCC Stage III/IV; Head and Neck Neoplasms

Treatments: Other: Chemoradiation plus Cetuximab; Other: Chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01301248

EEEK2008RCT2

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• prior radiotherapy
• chemotherapy
• concurrent active malignancies
• pregnancy
• breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Radiotherapy/Cisplatin(GroupA)

Active Comparator group

Description:

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

Treatment:

Other: Chemoradiation

Radiotherapy/Cisplatin/Cetuximab(GroupB)

Experimental group

Description:

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)

Treatment:

Other: Chemoradiation plus Cetuximab