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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Theagenio Cancer Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Theagenio Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01301248
First received: February 22, 2011
Last updated: May 16, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Head and Neck Neoplasms
AJCC Stage III/IV
Other: Chemoradiation plus Cetuximab
Other: Chemoradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Theagenio Cancer Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301248

Locations
Greece
Theagenio Cancer Hospital
Thessaloniki, Greece, 54007
Sponsors and Collaborators
Theagenio Cancer Hospital
Investigators
Principal Investigator: Charalambos Andreadis, MD Theagenio Cancer Hospital
  More Information

No publications provided

Responsible Party: Charalambos Andreadis MD, PhD, Theagenio Cancer Hospital
ClinicalTrials.gov Identifier: NCT01301248     History of Changes
Other Study ID Numbers: EEEK2008RCT2
Study First Received: February 22, 2011
Last Updated: May 16, 2011
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

Keywords provided by Theagenio Cancer Hospital:
locally advanced,
unresectable,
head and neck squamous cell carcinoma,
stage III/IV

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014