Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer (MORRIS)
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| ClinicalTrials.gov Identifier: NCT02379039 |
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Recruitment Status :
Completed
First Posted : March 4, 2015
Last Update Posted : December 22, 2023
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| Condition or disease |
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| Squamous Carcinoma Head and Neck Cancer Anal Cancer Lung Cancer Esophageal Cancer Cervix Cancer |
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 |
| Actual Enrollment : | 118 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 |
| Study Start Date : | May 2015 |
| Actual Primary Completion Date : | May 2023 |
| Actual Study Completion Date : | May 2023 |
- Loco regional control [ Time Frame: 2 years ]After completion of radiotherapy
- 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
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379039
| Sweden | |
| Umeå University | |
| Umeå, Sweden, SE-901 85 | |
| Principal Investigator: | Björn Zackrisson, Professor | Umeå University, Department of Radiation Sciences - Oncology |
| Responsible Party: | Umeå University |
| ClinicalTrials.gov Identifier: | NCT02379039 |
| Other Study ID Numbers: |
MORRIS_1 |
| First Posted: | March 4, 2015 Key Record Dates |
| Last Update Posted: | December 22, 2023 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | If relevant, anonymized data may be shared. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) 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) |
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Anus Neoplasms Neoplasms, Squamous Cell Carcinoma, Squamous Cell Uterine Cervical Neoplasms Neoplasms by Site Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Intestinal Diseases Anus Diseases |
Rectal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |