Trial Title:
Adaptive Radiation Treatment for Head and Neck Cancer
NCT ID:
NCT01504815
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Cisplatin
Conditions: Keywords:
advanced head and neck cancer
adaptive radiotherapy
cisplatinum
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cisplatinum
Description:
i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
Arm group label:
Cisplatinum + adaptive high dose RT
Arm group label:
Cisplatinum + conventional RT
Intervention type:
Radiation
Intervention name:
Conventional radiotherapy
Description:
conventional radiotherapy, 70Gy in 7 weeks
Arm group label:
Cisplatinum + conventional RT
Intervention type:
Radiation
Intervention name:
Adaptive radiotherapy
Description:
adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
Arm group label:
Cisplatinum + adaptive high dose RT
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy Cancer Institute
Address:
City:
Villejuif
Zip:
94800
Country:
France
Facility:
Name:
Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Facility:
Name:
Maastro Clinic
Address:
City:
Maastricht
Zip:
NL-6229 ET
Country:
Netherlands
Facility:
Name:
Erasmus Medical Centre
Address:
City:
Rotterdam
Zip:
3075 EA
Country:
Netherlands
Facility:
Name:
University Medical Centre Utrecht
Address:
City:
Utrecht
Zip:
NL-3508GA
Country:
Netherlands
Facility:
Name:
University Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Karolinska Institute
Address:
City:
Stockholm
Zip:
17177
Country:
Sweden
Facility:
Name:
Christie Hospital NHS Trust
Address:
City:
Manchester
Zip:
M20 5BX
Country:
United Kingdom
Start date:
September 7, 2012
Completion date:
December 2024
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Maastricht Radiation Oncology
Agency class:
Other
Collaborator:
Agency:
Institut Catala de Salut
Agency class:
Other
Collaborator:
Agency:
The Christie NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Collaborator:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
European Union
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01504815
