- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02379039
Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer (MORRIS)
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 Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Björn Zackrisson, Professor
- Phone Number: 1564 +46907850000
- Email: bjorn.zackrisson@umu.se
Study Contact Backup
- Name: Karin Söderström, MD
- Phone Number: +46907850000
- Email: karin.soderstrom@onkologi.umu.se
Study Locations
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Umeå, Sweden, SE-901 85
- Umea University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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/1.73m2.
- Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.
Study Plan
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
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After completion of radiotherapy
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loco regional tumour control (response)
Time Frame: 2 months
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After completion of radiotherapy
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2 months
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Patterns of failure
Time Frame: 2 years
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Time and location of recurrence
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2 years
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Overall survival
Time Frame: 5 years
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After completion of radiotherapy
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5 years
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Changes in imaging and metabolic data
Time Frame: 1-2 weeks
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As measured 1-2 weeks after start of radiotherapy
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1-2 weeks
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Site specific toxicity
Time Frame: 1 year
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Measured as patient reported side-effects
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Björn Zackrisson, Professor, Umeå University, Department of Radiation Sciences - Oncology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Anus Neoplasms
Other Study ID Numbers
- MORRIS_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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