Adaptive Radiation Treatment for Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: cisplatinum
* Radiation: Conventional radiotherapy
* Radiation: Adaptive radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cisplatinum + conventional RT<br>Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks | Drug: cisplatinum<br>* i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy<br>Radiation: Conventional radiotherapy<br>* conventional radiotherapy, 70Gy in 7 weeks<br>|
| Experimental: Cisplatinum + adaptive high dose RT<br>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 | Drug: cisplatinum<br>* i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy<br>Radiation: Adaptive radiotherapy<br>* adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional recurrence-free survival |  | 2 years | 
| number of patients with grade 3 toxicity or more |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessment |  | 2 years | 
| swallowing preservation | Tube feeding dependency at one year | 1 year | 
| progression free survival |  | 2 years | 
| overall survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced head and neck cancer, adaptive radiotherapy, cisplatinum