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A Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer. (ARTSCANIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969877
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Study Description
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Brief Summary:
The primary endpoint in this study is to investigate if there is a difference in overall survival in patients with locally advanced head and neck cancer, randomized to either radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is performed in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy.

Condition or disease Intervention/treatment Phase
Locally Advanced Head and Neck Cancer Drug: cetuximab Drug: cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase III Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
Actual Study Start Date : November 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Radiotherapy with a dose of 68.0 Gy in 34 fractions, and cetuximab with a loading dose of 400 mg/m2 one week before start of radiotherapy, then 250 mg/m2 weekly during radiotherapy (tumor stage 1-4).
 Drug: cetuximab
Drug: cisplatin
Experimental: Arm 2
Radiotherapy with a dose of 73.1 Gy in 34 fractions, and cetuximab with a loading dose of 400 mg/m2 one week before start of radiotherapy, then 250 mg/m2 weekly during radiotherapy (tumor stage 3-4).
 Drug: cetuximab
Drug: cisplatin
Experimental: Arm 3
Radiotherapy with a dose of 68.0 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 1-4).
 Drug: cetuximab
Drug: cisplatin
Experimental: Arm 4
Radiotherapy with a dose of 73.1 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 3-4).
 Drug: cetuximab
Drug: cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18 years
  • Histologically or cytologically confirmed , previous untreated head and neck squamous cell cancer of the oral cavity, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent
  • Tumor stage III and IV , but no evidence of distant metastases beyond the regional nodes in the neck
  • WHO/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • The patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab
  • The patient must be able to understand the information about the treatment and give a written informed concent to participate in the trial
  • Adequate follow-up study must be possible; this will exclude a patient who is uncooperative
  • Adequate renal function, creatinine clearance over 50 ml/min/1.73 estimated according to local practice at each study centre

Exclusion Criteria:

  • Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years
  • Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years
  • Two or more synchronous primary head and neck squamous cell cancer at time of diagnosis
  • Co-existing disease prejudicing survival (expected survival less than 6 months)
  • Absolute neutrophil count less than 1.5 x 109/L
  • Platelet count less than 100 x 109/L
  • Bilirubin over 1.5 times upper limit of normal
  • Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) more than 3 times upper limit of normal
  • Pregnancy or lactation
  • Allergy to study drug or to the excipients in their formulation
  • Neuropathy grade 2 or more according to Common terminology criteria for adverse events (CTCAE) v.4.0
  • Hearing loss/tinnitus is a relative exclusion criteria; the responsible physician decides whether the patient may be included in the study
  • Severe cardiac illness; myocardial infarction within 6 months prior to randomization, severe congestive heart failure, severe cardiomyopathy, ventricular arrythmia, unstable angina, uncontrolled hypertension
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969877


Locations
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Sweden
Gävle Hospital
Gävle, Sweden
Sahlgrenska University Hospital
Göteborg, Sweden
County Hospital Ryhov
Jönköping, Sweden
Central Hospital
Karlstad, Sweden
University Hospital Linköping
Linköping, Sweden
Karolinska Universityhospital
Stockholm, Sweden
Norrland University Hospital
Umeå, Sweden
Västmanlands Hospital Västerås
Västerås, Sweden
University Hospital Örebro
Örebro, Sweden
Sponsors and Collaborators
Lund University Hospital
Investigators
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Principal Investigator: Maria Gebre-Medhin, MD, PhD Lund University Hospital
More Information
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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01969877    
Other Study ID Numbers: EudraCT number 2012-001879-37
2012-001879-37 ( EudraCT Number )
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Keywords provided by Lund University Hospital:
Head and neck cancer
Cetuximab
Cisplatin
Radiotherapy
 Quality of life
Human papilloma virus
Health economy
Biomarker investigations
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
 Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Immunological