Head and Neck CancerPhase 3ARTFORCENCT01504815
Adaptive Radiation Treatment for Head and Neck Cancer
A Phase 3 study testing cisplatinum, Conventional radiotherapy and Adaptive radiotherapy in people with Head and Neck Cancer, run by The Netherlands Cancer Institute at 9 sites in 5 countries.
Trial summary
This Phase III trial aims to: Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN. The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatinum, Conventional radiotherapy and Adaptive radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 7 Sep 2012to 24 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx
- stage III/IV, T3-4, Nx M0
- < 70 yrs
- glomerular filtration rate (GFR) >60
- WHO 0-1
- no previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- adequate bone marrow function, adequate hepatic function,informed consent
- >18 years
Who cannot join
- expected failure from follow-up
- previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- expected inability to complete either one of the treatment arms
- pregnancy or lactation
- patients (m/f) with reproductive potential not implementing adequate contraceptive measures
- prior surgery, radiotherapy or chemotherapy for this tumor
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- contraindications or serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or are likely to interfere with the study assessments
- known active symptomatic fungal, bacterial and/or viral infections including HIV
- concomitant (or with 4 weeks before randomisation) administration of any other experimental drug
- concurrent treatment with any other anti-cancer therapy
- prior treatment with one or more of the active compounds
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Netherlands5 sites
Netherlands Cancer Institute
Amsterdam, 1066CX
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Maastro Clinic
Maastricht, NL-6229 ET
Erasmus Medical Centre
Rotterdam, 3075 EA
University Medical Centre Utrecht
Utrecht, NL-3508GA
About this study
Official title: Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
This Phase III trial aims to:
Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.
The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.
To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatinum, Conventional radiotherapy, Adaptive radiotherapy
- Keywords
- advanced head and neck cancer, adaptive radiotherapy, cisplatinum
- 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.
cisplatinumDrug
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Conventional radiotherapyRadiation
conventional radiotherapy, 70Gy in 7 weeks
Adaptive radiotherapyRadiation
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatinum + conventional RT | Active comparator | Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks Receives: Drug: cisplatinum; Radiation: Conventional radiotherapy |
| Cisplatinum + adaptive high dose RT | Experimental | Cisplatinum, 100 mg/m2 on days 1, 22 and 43 with adaptive high dose RT to 84 Gy max on 50% uptake GTV in 7 weeks Receives: Drug: cisplatinum; Radiation: Adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional recurrence-free survival
Measured: 2 years
number of patients with grade 3 toxicity or more
Measured: 2 years
Secondary outcomes (4)
Quality of Life assessment
Measured: 2 years
swallowing preservation
Tube feeding dependency at one year
Measured: 1 year
progression free survival
Measured: 2 years
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study start7 Sep 2012
- Primary completion1 Dec 2021
- Study completion24 Dec 2024
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 Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Maastricht Radiation Oncology, Institut Catala de Salut, The Christie NHS Foundation Trust, Gustave Roussy, Cancer Campus, Grand Paris, UMC Utrecht, European Union
- Responsible party
- Sponsor
- Investigators
- Olga Hamming-Vrieze, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504815
- Sponsor's protocol ID
- M11ART
- Acronym
- ARTFORCE
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2011
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heukelom J, Hamming O, Bartelink H, Hoebers F, Giralt J, Herlestam T, Verheij M, van den Brekel M, Vogel W, Slevin N, Deutsch E, Sonke JJ, Lambin P, Rasch C. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer. BMC Cancer. 2013 Feb 22;13:84. doi: 10.1186/1471-2407-13-84.
PubMed 23433435
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01504815
- Acronym / sponsor ID
- ARTFORCE / M11ART
- Conditions
- Head and Neck Cancer
- Keywords
- advanced head and neck cancer, adaptive radiotherapy, cisplatinum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Maastricht Radiation Oncology, Institut Catala de Salut, The Christie NHS Foundation Trust, Gustave Roussy, Cancer Campus, Grand Paris, UMC Utrecht, European Union
- Study start
- 7 Sep 2012 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 5 Jan 2012 (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.
This Phase III trial aims to:
Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.
The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.
To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatinum + conventional RT | Active comparator | Drug: cisplatinum, Radiation: Conventional radiotherapyCisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks |
| Cisplatinum + adaptive high dose RT | Experimental | Drug: cisplatinum, Radiation: Adaptive radiotherapyCisplatinum, 100 mg/m2 on days 1, 22 and 43 with adaptive high dose RT to 84 Gy max on 50% uptake GTV in 7 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx
- stage III/IV, T3-4, Nx M0
- < 70 yrs
- glomerular filtration rate (GFR) >60
- WHO 0-1
Key exclusion criteria (11 listed)
- expected failure from follow-up
- previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
- expected inability to complete either one of the treatment arms
- pregnancy or lactation
- patients (m/f) with reproductive potential not implementing adequate contraceptive measures
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 |
|---|---|---|
| cisplatinumi.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy | Drug | Cisplatinum + adaptive high dose RT, Cisplatinum + conventional RT |
| Conventional radiotherapyconventional radiotherapy, 70Gy in 7 weeks | Radiation | Cisplatinum + conventional RT |
| Adaptive radiotherapyadaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks | Radiation | Cisplatinum + adaptive high dose RT |
Primary outcome
locoregional recurrence-free survival
Time frame: 2 years
number of patients with grade 3 toxicity or more
Time frame: 2 years
4 secondary outcomes
Quality of Life assessment
Time frame: 2 years
swallowing preservation
Time frame: 1 year
progression free survival
Time frame: 2 years
overall survival
Time frame: 2 years
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 29 Jan 2025.
- Derived from this study: PubMed 23433435Heukelom J, Hamming O, Bartelink H, Hoebers F, Giralt J, Herlestam T, Verheij M, van den Brekel M, Vogel W, Slevin N, Deutsch E, Sonke JJ, Lambin P, Rasch C. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer. BMC Cancer. 2013 Feb 22;13:84. doi: 10.1186/1471-2407-13-84.
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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.
Olga Hamming-Vrieze, MD principal investigator
The Netherlands Cancer Institute
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatinum, Conventional radiotherapy and Adaptive radiotherapy in people with Head and Neck Cancer, run by The Netherlands Cancer Institute at 9 sites in 5 countries.
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 11 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 29 Jan 2025. 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 Netherlands, France, Spain, Sweden, United Kingdom. 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?
locoregional recurrence-free survival (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT01504815, 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 29 Jan 2025.