Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

Lung Cancer Clinical Trial

— MORRIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379039
• Other study ID #: MORRIS_1
• Status: Completed
• Start date: May 2015
• Est. completion date: May 2023

Study information

• Verified date: December 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Carcinoma, Squamous Cell
• Cervix Cancer
• Esophageal Cancer
• Head and Neck Cancer
• Lung Cancer
• Neoplasms, Squamous Cell
• Squamous Carcinoma
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

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