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

Head and Neck Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01301248
• Other study ID #: EEEK2008RCT2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 22, 2011
• Last updated: May 16, 2011
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: April 2011
• Source: Theagenio Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AJCC Stage III/IV
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

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)
• Chemoradiation
Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2

Locations

Country	Name	City	State
Greece	Theagenio Cancer Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Theagenio Cancer Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes