Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
268 participants
INTERVENTIONAL
2012-09-07
2024-12-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cisplatinum + conventional RT
Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks
cisplatinum
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Conventional radiotherapy
conventional radiotherapy, 70Gy in 7 weeks
Cisplatinum + adaptive high dose RT
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
cisplatinum
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Adaptive radiotherapy
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
Interventions
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cisplatinum
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Conventional radiotherapy
conventional radiotherapy, 70Gy in 7 weeks
Adaptive radiotherapy
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Maastricht Radiation Oncology
OTHER
Institut Catala de Salut
OTHER_GOV
The Christie NHS Foundation Trust
OTHER
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
UMC Utrecht
OTHER
European Union
OTHER
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Olga Hamming-Vrieze, MD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
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Gustave Roussy Cancer Institute
Villejuif, , France
Netherlands Cancer Institute
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Maastro Clinic
Maastricht, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
University Medical Centre Utrecht
Utrecht, , Netherlands
University Hospital Vall d'Hebron
Barcelona, , Spain
Karolinska Institute
Stockholm, , Sweden
Christie Hospital NHS Trust
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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M11ART
Identifier Type: -
Identifier Source: org_study_id
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