Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Squamous Carcinoma
- Sponsor
- Umeå University
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Loco regional control
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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/1.73m
- •Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.
Outcomes
Primary Outcomes
Loco regional control
Time Frame: 2 years
After completion of radiotherapy
Secondary Outcomes
- Patterns of failure(2 years)
- Site specific toxicity(1 year)
- Loco regional tumour control (response)(2 months)
- Overall survival(5 years)
- Changes in imaging and metabolic data(1-2 weeks)