Chemo-radiotherapy as Main Treatment Strategy for Rectal Cancer. Can we Provide a More Precise and Effective Treatment

NCT03619668 | Unknown DMC

• 1 other identifier: N-20170064
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to obtain important information about the tumour and surrounding organs during preoperative chemo-radiotherapy for patients with adenocarcinoma of the rectum. The knowledge generated in this project has the potential to make future radiotherapy treatments (RT) of rectal cancer patients more precise, with less side effects. This could lead the way to make chemo-radiotherapy the main treatment modality and spare a large group of patients from the risk of severe complications after surgery. Specifically, we aim to obtain:

• A characterization of systematic and random changes in position and shape of tumours and surrounding organs during RT.
• A patient-specific pre-treatment characterization of random uncertainties in position and shape of the tumour during radiotherapy. This will be used to create and assess an individual, patient-specific treatment strategy, with the possibility to implement an adaptive RT strategy using the information obtained from the MRI-scans during treatment.
• Information about treatment response and local toxicity from morphological and functional data before, during and after CRT.

Conditions

Rectal Cancer; Rectal Adenocarcinoma; Locally Advanced Malignant Neoplasm

Keywords

Effect of radiotherapy

Outcome Measures

Primary Outcomes (1)

• Changes in position and shape of the tumour during RT.

  Use additional MRI scans before radiotherapy (for random changes) and during radiotherapy (for systematic changes). The gross tumor volume (GTV), clinical target volume (CTV) will be delineated separately on CT and all MRI-scans. Using a rigid bony anatomy-based method, the MRI-scans will be registered to the planning CT scan, to allow a comparison of the position and shape variations of the volumes. The information gained will be used to evaluate the relevance of current population based planning target volume (PTV) margins, and, if relevant, provide updated recommendations for treatment margins.

  Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days

Secondary Outcomes (5)

• Changes in position and shape of organs during RT.

  Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days

• Patient specific pre-treatment systematic changes in position and shape of CTV during radiotherapy.

  Baseline, 3-4 days, an average of 9 days.

• Change in treated volume using adaptive radiotherapy

  Baseline, an average of 7 days, an average of 14 days, average of 28 days

• Change in the functional imaging parameter: ADC-value.

  Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days, an average of 1 year, an average of 2 years, an average of 3 years

• Change in functional imaging parameter: Ktrans.

  Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days, an average of 1 year, an average of 2 years, an average of 3 years

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 referred to standard chemoradiotherapy for locally advanced rectal cancer.

You may qualify if:

• All patients referred to standard chemoradiotherapy for locally advanced rectal cancer.

You may not qualify if:

• Prior surgery in pelvic minor region
• Pacemaker
• Neurostimulator
• Other non MR-compatible implants
• Pregnancy
• Incapable of undergoing MRI
• Incapable of understanding the patient information
• Allergic to contrast agent
• Contraindication for Buscopan

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dennis T. Arp, Medical Physicist

  Department of Medical Physics, Oncology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Physicist

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 8, 2018
• Study Start: June 29, 2018
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

DK (1)