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

NCT ID: NCT01969877

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

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).

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

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).

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

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).

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

Interventions

cetuximab

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Gebre-Medhin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital

Locations

Gävle Hospital

Gävle, , Sweden

Sahlgrenska University Hospital

Gothenburg, , Sweden

County Hospital Ryhov

Jönköping, , Sweden

Central Hospital

Karlstad, , Sweden

University Hospital Linköping

Linköping, , Sweden

University Hospital Örebro

Örebro, , Sweden

Karolinska Universityhospital

Stockholm, , Sweden

Norrland University Hospital

Umeå, , Sweden

Västmanlands Hospital Västerås

Västerås, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33052757 (View on PubMed)

Other Identifiers

2012-001879-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT number 2012-001879-37

Identifier Type: -

Identifier Source: org_study_id