Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

NCT02379039 | Completed DMC

• 1 other identifier: MORRIS_1
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Carcinoma; Head and Neck Cancer; Anal Cancer; Lung Cancer; Esophageal Cancer; Cervix Cancer

Outcome Measures

Primary Outcomes (1)

• Loco regional control

  After completion of radiotherapy

  2 years

Secondary Outcomes (5)

• Loco regional tumour control (response)

  2 months

• Patterns of failure

  2 years

• Overall survival

  5 years

• Changes in imaging and metabolic data

  1-2 weeks

• Site specific toxicity

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Lund University: collaborator

Study Sites (1)

Umeå University

Umeå, SE-901 85, Sweden

Location

Related Publications (1)

• Strandberg S, Jonsson J, Zarei M, Aglund K, Blomqvist L, Soderkvist K. Baseline and early response 2-[18F]FDG-PET/MRI for prediction of radiotherapy outcome in uterine cervical squamous cell carcinoma: a prospective single-center observational cohort study. EJNMMI Rep. 2024 Mar 1;8(1):5. doi: 10.1186/s41824-024-00188-7.

  PMID: 38748271 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumour biopsies, plasma

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms; Anus Neoplasms; Lung Neoplasms; Esophageal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; 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

Study Officials

• Björn Zackrisson, Professor

  Umeå University, Department of Radiation Sciences - Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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)

Locations

SE (1)