Overview

This trial is active, not recruiting.

Conditions head and neck neoplasms, ajcc stage iii/iv
Treatments chemoradiation plus cetuximab, chemoradiation
Phase phase 2
Sponsor Theagenio Cancer Hospital
Start date March 2008
End date April 2011
Trial size 80 participants
Trial identifier NCT01301248, EEEK2008RCT2

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)
chemoradiation Platinol
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2
(Experimental)
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)
chemoradiation plus cetuximab Platinol
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 Outcomes

Measure
Determine safety and toxicity of combination
time frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months

Secondary Outcomes

Measure
Overall survival time
time frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Progression-free survival time
time frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Response
time frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
Principal investigator Charalambos Andreadis, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Theagenio Cancer Hospital.