Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

Study Overview
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Brief Summary
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The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.

Detailed Description
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Patients with squamous cell carcinoma of the head & neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters. The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.

Official Title
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Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy

Conditions
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Squamous Carcinoma, Head and Neck Cancer, Anal Cancer, Lung Cancer, Esophageal Cancer, Cervix Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung. The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate Exclusion Criteria: The patient is unwilling to participate in the study Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour) Pregnancy or lactation Contraindications to investigations with MRI, gadolinium contrast or PET-tracers Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m2. Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco regional control | After completion of radiotherapy | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco regional tumour control (response) | After completion of radiotherapy | 2 months | 
| Patterns of failure | Time and location of recurrence | 2 years | 
| Overall survival | After completion of radiotherapy | 5 years | 
| Changes in imaging and metabolic data | As measured 1-2 weeks after start of radiotherapy | 1-2 weeks | 
| Site specific toxicity | Measured as patient reported side-effects | 1 year |