Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer (MORRIS)

December 21, 2023 updated by: Umeå University

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Umeå, Sweden, SE-901 85
        • Umea University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Björn Zackrisson, Professor, Umeå University, Department of Radiation Sciences - Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimated)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If relevant, anonymized data may be shared.

IPD Sharing Time Frame

The data will become available 6 months after publication

IPD Sharing Access Criteria

Metaanalysis, comprehensive review. Request is sent to principal investigator (Bjorn Zackrisson)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Subscribe