Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT02379039
• Date of registration: 26/02/2015
• Prospective Registration: Yes
• Primary sponsor: Umeå University
• Public title: Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer MORRIS
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 118
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02379039
• Study type: Observational

Countries of recruitment

Sweden

Contacts

• Name: Björn Zackrisson, Professor
• Affiliation: Umeå University, Department of Radiation Sciences - Oncology

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Esophageal Cancer

Anal Cancer

Lung Cancer

Cervix Cancer

Head and Neck Cancer

Squamous Carcinoma

Primary Outcome(s)

Loco regional control [Time Frame: 2 years]

Secondary Outcome(s)

Loco regional tumour control (response) [Time Frame: 2 months]

Changes in imaging and metabolic data [Time Frame: 1-2 weeks]

Patterns of failure [Time Frame: 2 years]

Site specific toxicity [Time Frame: 1 year]

Overall survival [Time Frame: 5 years]

Secondary ID(s)

MORRIS_1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lund University