Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

Completed

• Conditions: Squamous Carcinoma; Cervix Cancer; Anal Cancer; Head and Neck Cancer; Lung Cancer; Esophageal Cancer

• Registration Number: NCT02379039
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Study Start: 2015-05
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loco regional control	2 years	After completion of radiotherapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden