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Completed

NCT Number: NCT02379039

Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

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.

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Key information

Conditions

Squamous Carcinoma Anal Cancer Anus Diseases Anus Neoplasms Carcinoma Carcinoma, Squamous Cell Cervix Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University

Umeå, SE-901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Loco regional control

    Time frame: 2 years

    After completion of radiotherapy

Secondary outcomes

  1. Loco regional tumour control (response)

    Time frame: 2 months

    After completion of radiotherapy

  2. Patterns of failure

    Time frame: 2 years

    Time and location of recurrence

  3. Overall survival

    Time frame: 5 years

    After completion of radiotherapy

  4. Changes in imaging and metabolic data

    Time frame: 1-2 weeks

    As measured 1-2 weeks after start of radiotherapy

  5. Site specific toxicity

    Time frame: 1 year

    Measured as patient reported side-effects

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Lund University

Registry information

Official study 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

Acronym: MORRIS

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2015
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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