Adaptive Radiation Treatment for Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Drug: cisplatinumRadiation: Conventional radiotherapyRadiation: Adaptive radiotherapy
- Registration Number
- NCT01504815
- Lead Sponsor
- The Netherlands Cancer Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cisplatinum + adaptive high dose RT cisplatinum 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 + conventional RT Conventional radiotherapy Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks Cisplatinum + conventional RT cisplatinum Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks Cisplatinum + adaptive high dose RT Adaptive radiotherapy 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
- Primary Outcome Measures
Name Time Method locoregional recurrence-free survival 2 years number of patients with grade 3 toxicity or more 2 years
- Secondary Outcome Measures
Name Time Method swallowing preservation 1 year Tube feeding dependency at one year
progression free survival 2 years overall survival 2 years Quality of Life assessment 2 years
Trial Locations
- Locations (9)
University Medical Centre Utrecht
π³π±Utrecht, Netherlands
Gustave Roussy Cancer Institute
π«π·Villejuif, France
Karolinska Institute
πΈπͺStockholm, Sweden
Erasmus Medical Centre
π³π±Rotterdam, Netherlands
University Hospital Vall d'Hebron
πͺπΈBarcelona, Spain
Christie Hospital NHS Trust
π¬π§Manchester, United Kingdom
Netherlands Cancer Institute
π³π±Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
π³π±Groningen, Netherlands
Maastro Clinic
π³π±Maastricht, Netherlands