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

NCT01969877 | Completed Phase 3

• 2 other identifiers: EudraCT number 2012-001879-372012-001879-37
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 9

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.

Conditions

Locally Advanced Head and Neck Cancer

Keywords

Head and neck cancer; Cetuximab; Cisplatin; Radiotherapy; Quality of life; Human papilloma virus; Health economy; Biomarker investigations

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Arm 3

EXPERIMENTAL

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

Arm 4

EXPERIMENTAL

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

Interventions

cetuximab DRUG

Arm 1; Arm 2; Arm 3; Arm 4

cisplatin DRUG

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe cardiac illness; myocardial infarction within 6 months prior to randomization, severe congestive heart failure, severe cardiomyopathy, ventricular arrythmia, unstable angina, uncontrolled hypertension

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (9)

Gävle Hospital

Gävle, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

County Hospital Ryhov

Jönköping, Sweden

Location

Central Hospital

Karlstad, Sweden

Location

University Hospital Linköping

Linköping, Sweden

Location

University Hospital Örebro

Örebro, Sweden

Location

Karolinska Universityhospital

Stockholm, Sweden

Location

Norrland University Hospital

Umeå, Sweden

Location

Västmanlands Hospital Västerås

Västerås, Sweden

Location

Related Publications (1)

• Gebre-Medhin M, Brun E, Engstrom P, Haugen Cange H, Hammarstedt-Nordenvall L, Reizenstein J, Nyman J, Abel E, Friesland S, Sjodin H, Carlsson H, Soderkvist 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.

  PMID: 33052757 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Maria Gebre-Medhin, MD, PhD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 25, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

SE (9)