Clinical trial NCT01504815: Adaptive Radiation Treatment for Head and Neck Cancer
Official title: Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: advanced head and neck cancer
adaptive radiotherapy
cisplatinum
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Maastricht Radiation Oncology
name: Institut Catala de Salut
name: The Christie NHS Foundation Trust
name: Gustave Roussy, Cancer Campus, Grand Paris
name: UMC Utrecht
name: European Union
First posted: 2012-01-05
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: locoregional recurrence-free survival
timeFrame: 2 years
measure: number of patients with grade 3 toxicity or more
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life assessment
timeFrame: 2 years
measure: swallowing preservation
timeFrame: 1 year
measure: progression free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Institute
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Maastricht
country: Netherlands
facility: Maastro Clinic
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Stockholm
country: Sweden
facility: Karolinska Institute
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
Study officials:
affiliation: The Netherlands Cancer Institute
name: Olga Hamming-Vrieze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.