Back to resultsCisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
Primary Purpose
Head and Neck Neoplasms, AJCC Stage III/IV
Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Chemoradiation plus Cetuximab
Chemoradiation
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring locally advanced,, unresectable,, head and neck squamous cell carcinoma,, stage III/IV
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
Sites / Locations
- Theagenio Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiotherapy/Cisplatin(GroupA)
Radiotherapy/Cisplatin/Cetuximab(GroupB)
Arm Description
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)
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)
Outcomes
Primary Outcome Measures
Determine safety and toxicity of combination
Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01301248
First Posted
February 22, 2011
Last Updated
May 16, 2011
Sponsor
Theagenio Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01301248
Brief Title
Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Theagenio Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, AJCC Stage III/IV
Keywords
locally advanced,, unresectable,, head and neck squamous cell carcinoma,, stage III/IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy/Cisplatin(GroupA)
Arm Type
Active Comparator
Arm Description
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)
Arm Title
Radiotherapy/Cisplatin/Cetuximab(GroupB)
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Chemoradiation plus Cetuximab
Other Intervention Name(s)
Platinol, Erbitux
Intervention 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)
Intervention Type
Other
Intervention Name(s)
Chemoradiation
Other Intervention Name(s)
Platinol
Intervention Description
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2
Primary Outcome Measure Information:
Title
Determine safety and toxicity of combination
Description
Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
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 Outcome Measure Information:
Title
Overall survival time
Description
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 Frame
Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Title
Progression-free survival time
Description
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 Frame
Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Title
Response
Description
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 Frame
Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charalambos Andreadis, MD
Organizational Affiliation
Theagenio Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Theagenio Cancer Hospital
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
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