Locally Advanced Head and Neck CancerPhase 3ARTSCANIIINCT01969877
A Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
A Phase 3 study testing cetuximab and cisplatin in people with Locally Advanced Head and Neck Cancer, run by Lund University Hospital at 9 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Cancer
- What is being tested?
- cetuximab and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 9 sitesSweden
- Study dates
- Nov 2013to Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Gävle Hospital
Gävle
Sahlgrenska University Hospital
Gothenburg
County Hospital Ryhov
Jönköping
Central Hospital
Karlstad
University Hospital Linköping
Linköping
University Hospital Örebro
Örebro
Karolinska Universityhospital
Stockholm
Norrland University Hospital
Umeå
Västmanlands Hospital Västerås
Västerås
About this study
Official title: A Randomized Multicenter Phase III Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
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
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: cetuximab; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Gebre-Medhin, MD, PhD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969877
- Sponsor's protocol ID
- EudraCT number 2012-001879-37
- Other IDs
- 2012-001879-37
- Acronym
- ARTSCANIII
- Status last verified
- Sep 2020
- First submitted
- 16 Oct 2013
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33052757
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase III Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT01969877
- Acronym / sponsor ID
- ARTSCANIII / EudraCT number 2012-001879-37
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: cetuximab, Drug: cisplatinRadiotherapy 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). |
| Arm 2 | Experimental | Drug: cetuximab, Drug: cisplatinRadiotherapy 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). |
| Arm 3 | Experimental | Drug: cetuximab, Drug: cisplatinRadiotherapy with a dose of 68.0 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 1-4). |
| Arm 4 | Experimental | Drug: cetuximab, Drug: cisplatinRadiotherapy with a dose of 73.1 Gy in 34 fractions, and cisplatin weekly with a dose of 40 mg/m2 (tumor stage 3-4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetuximab | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| cisplatin | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Overall survival
Time frame: Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 33052757Gebre-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Gebre-Medhin, MD, PhD principal investigator
Lund University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cetuximab and cisplatin in people with Locally Advanced Head and Neck Cancer, run by Lund University Hospital at 9 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Every 3 month for 2 years, and every 6 month until 5 years for evaluation of overall survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01969877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.