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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379039
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : December 22, 2023
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Umeå University

Tracking Information
First Submitted Date February 26, 2015
First Posted Date March 4, 2015
Last Update Posted Date December 22, 2023
Study Start Date May 2015
Actual Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2017)		 Loco regional control [ Time Frame: 2 years ]
After completion of radiotherapy
Original Primary Outcome Measures
 (submitted: March 3, 2015)		 Loco regional control [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: October 25, 2017)
  • Loco regional tumour control (response) [ Time Frame: 2 months ]
    After completion of radiotherapy
  • Patterns of failure [ Time Frame: 2 years ]
    Time and location of recurrence
  • Overall survival [ Time Frame: 5 years ]
    After completion of radiotherapy
  • Changes in imaging and metabolic data [ Time Frame: 1-2 weeks ]
    As measured 1-2 weeks after start of radiotherapy
  • Site specific toxicity [ Time Frame: 1 year ]
    Measured as patient reported side-effects
Original Secondary Outcome Measures
 (submitted: March 3, 2015)
  • Loco regional tumour control (response) [ Time Frame: 2 months ]
    After completion of radiotherapy
  • Patterns of failure [ Time Frame: 2 years ]
    Time and location of recurrence
  • Overall survival [ Time Frame: 5 years ]
  • Changes in imaging and metabolic data [ Time Frame: 1-2 weeks ]
  • Site specific toxicity [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumour biopsies, plasma
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.
Condition
  • Squamous Carcinoma
  • Head and Neck Cancer
  • Anal Cancer
  • Lung Cancer
  • Esophageal Cancer
  • Cervix Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2023)		 118
Original Estimated Enrollment
 (submitted: March 3, 2015)		 412
Actual Study Completion Date May 2023
Actual Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02379039
Other Study ID Numbers MORRIS_1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: If relevant, anonymized data may be shared.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: The data will become available 6 months after publication
Access Criteria: Metaanalysis, comprehensive review. Request is sent to principal investigator (Bjorn Zackrisson)
Current Responsible Party Umeå University
Original Responsible Party Same as current
Current Study Sponsor Umeå University
Original Study Sponsor Same as current
Collaborators Lund University
Investigators
Principal Investigator: Björn Zackrisson, Professor Umeå University, Department of Radiation Sciences - Oncology
PRS Account Umeå University
Verification Date December 2023