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

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)

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

Study Overview

• Status: Unknown
• Conditions: Head and Neck Neoplasms; AJCC Stage III/IV
• Intervention / Treatment: Other: Chemoradiation; Other: Chemoradiation plus Cetuximab

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54007
    • Theagenio Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiotherapy/Cisplatin(GroupA); Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)	Other: Chemoradiation; Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2; Other Names: Platinol
Experimental: 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)	Other: 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); Other Names: Platinol; Erbitux

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival time	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.	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	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.	Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Response	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.	Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months

Collaborators and Investigators

• Sponsor: Theagenio Cancer Hospital
• Investigators: Principal Investigator: Charalambos Andreadis, MD, Theagenio Cancer Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): May 17, 2011
• Last Update Submitted That Met QC Criteria: May 16, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: head and neck squamous cell carcinoma,; locally advanced,; unresectable,; stage III/IV
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cisplatin; Cetuximab
• Other Study ID Numbers: EEEK2008RCT2