Search for more clinical trials
Adaptive Radiation Treatment for Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
advanced head and neck cancer, adaptive radiotherapy, cisplatinum
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatinum
Type: Drug
Name: Conventional radiotherapy
Type: Radiation
Name: Adaptive radiotherapy
Type: Radiation
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Locations
Gustave Roussy Cancer Institute
Villejuif, France
Netherlands Cancer Institute
Status: Not yet recruiting
Contact: Yungan Tao, MD - +33 1 42116532 - yungan.tao@gustaveroussy.fr
Amsterdam, Netherlands
Maastro Clinic
Status: Recruiting
Contact: Olga Hamming-Vrieze, MD - +31205122135 - o.vrieze@nki.nl
Maastricht, Netherlands
University Medical Centre
Status: Recruiting
Contact: Frank Hoebers, MD - +31 88 4455521 - frank.hoebers@maastro.nl
Utrecht, Netherlands
University Hospital Vall d'Hebron
Status: Not yet recruiting
Contact: Chris Terhaard, MD PhD - +31 88 7553137 - c.h.j.terhaard@umcutrecht.nl
Barcelona, Spain
Karolinska Institute
Status: Recruiting
Contact: Jordi Giralt, MD - jgiralt@vhebron.net
Stockholm, Sweden
Christie Hospital NHS Trust
Status: Not yet recruiting
Contact: Teresa Herlestam, MD - +46 8 51770000 - maria.herlestam-calero-moreno@karolinska.se
Manchester, United Kingdom
Status: Not yet recruiting
Contact: Nick Slevin, MD - +44 161 9187939 - nick.slevin@christie.nhs.uk
Start Date
March 2012
Completion Date
March 2019
Sponsors
The Netherlands Cancer Institute
Source
The Netherlands Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page