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)

Theagenio Cancer Hospital1 site in 1 country80 target enrollmentMarch 2008

ConditionsHead and Neck Neoplasms AJCC Stage III/IV

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Neoplasms
Sponsor: Theagenio Cancer Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: Determine safety and toxicity of combination
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Theagenio Cancer Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.

Secondary Outcomes

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)
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)
Response(Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months)