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

Phase 2

• Conditions: Head and Neck Neoplasms; AJCC Stage III/IV
• Interventions: Other: Chemoradiation; Other: Chemoradiation plus Cetuximab

• Registration Number: NCT01301248
• Lead Sponsor: Theagenio Cancer Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy/Cisplatin(GroupA)	Chemoradiation	Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)
Radiotherapy/Cisplatin/Cetuximab(GroupB)	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)

Primary Outcome Measures

Name	Time	Method
Determine safety and toxicity of combination	Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months	Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.

Secondary Outcome Measures

Name	Time	Method
Overall survival time	Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months	Time from first administration of trial treatment to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Progression-free survival time	Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months	Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Patients without event are censored on the date of last tumor assessment.
Response	Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months	Complete response (CR) is defined as the total disappearance of radiographic evidence of tumour. Partial response (PR) is defined as the ≥50% reduction in the product of the maximal bidimensional tumour diameters. Stable disease defined any change between +25% and -50% in tumour size, and progressive disease included any increase \>25% from baseline or the appearance of any new lesion. We record tumour shrinkage and time to the development of disease progression according to the revised RECIST criteria, v.1.1.

Trial Locations

Locations (1)

Theagenio Cancer Hospital; 🇬🇷 Thessaloniki, Greece