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

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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

Tracking Information
First Submitted Date  ICMJE October 16, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
Overall survival [ Time Frame: Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
Official Title  ICMJE A Randomized Multicenter Phase III Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Head and Neck Cancer
Intervention  ICMJE
  • Drug: cetuximab
  • Drug: cisplatin
Study Arms  ICMJE
  • 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).
    Interventions:
    • 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).
    Interventions:
    • 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).
    Interventions:
    • 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).
    Interventions:
    • Drug: cetuximab
    • Drug: cisplatin
Publications * Gebre-Medhin M, Brun E, Engström P, Haugen Cange H, Hammarstedt-Nordenvall L, Reizenstein J, Nyman J, Abel E, Friesland S, Sjödin H, Carlsson H, Söderkvist K, Thomasson M, Zackrisson B, Nilsson P. ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer. J Clin Oncol. 2021 Jan 1;39(1):38-47. doi: 10.1200/JCO.20.02072. Epub 2020 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2020)
298
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2013)
618
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969877
Other Study ID Numbers  ICMJE EudraCT number 2012-001879-37
2012-001879-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lund University Hospital
Study Sponsor  ICMJE Lund University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Gebre-Medhin, MD, PhD Lund University Hospital
PRS Account Lund University Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP