Clinical trial NCT02379039: Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer
Official title: Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Carcinoma
Head and Neck Cancer
Anal Cancer
Lung Cancer
Esophageal Cancer
Cervix Cancer
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2015-03-04
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previously untreated squamous carcinoma aimed for radiotherapy with curative intent of the oral cavity, oropharynx, uterine cervix, oesophagus, anal canal or lung.

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.

Eligibility criteria: Inclusion Criteria:

1. Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
2. The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
3. The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
4. 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:

1. The patient is unwilling to participate in the study
2. Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
3. Pregnancy or lactation
4. Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
5. Patients with an estimated glomerular filtration rate (GFR) \<60 ml/min/1.73m2.
6. Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.

Primary outcomes:
measure: Loco regional control
timeFrame: 2 years
Secondary outcomes:
measure: Loco regional tumour control (response)
timeFrame: 2 months
measure: Patterns of failure
timeFrame: 2 years
measure: Overall survival
timeFrame: 5 years
measure: Changes in imaging and metabolic data
timeFrame: 1-2 weeks
measure: Site specific toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University, Department of Radiation Sciences - Oncology
name: Björn Zackrisson, Professor
role: PRINCIPAL_INVESTIGATOR
References: