Rectal CancerAMPERENCT03619668
Chemo-radiotherapy as Main Treatment Strategy for Rectal Cancer. Can we Provide a More Precise and Effective Treatment
An observational study of Rectal Cancer and Rectal Adenocarcinoma, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectal Adenocarcinoma, Locally Advanced Malignant Neoplasm
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Jun 2018to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to standard chemoradiotherapy for locally advanced rectal cancer.
Who may be able to join
- All patients referred to standard chemoradiotherapy for locally advanced rectal cancer.
Who cannot join
- Prior surgery in pelvic minor region
- Pacemaker
- Neurostimulator
- Other non MR-compatible implants
- Pregnancy
- Incapable of undergoing MRI
Show all 10Show fewer
- Incapable of understanding the patient information
- Allergic to contrast agent
- Contraindication for Buscopan
- Reduced renal function (GFR < 50 ml/min) Patients who cannot tolerate the contrast used for DCE-MRI (due to allergies, contraindications for Buscopan or reduced renal function (GFR < 50 ml/min)) will still be offered inclusion in the study, but without the contrast-based MRI scans.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Patients diagnosed with locally advanced adenocarcinoma of the rectum are treated with concomitant chemo-radiotherapy (CRT), with the aim of reducing local recurrences. Depending on tumor location, this is a pre-operative procedure prior to total mesorectal excision or partial mesorectal excision. The surgery is associated with a high risk of postoperative morbidity, however, especially when combined with CRT. Consequently, recent years have seen an increasing focus on other therapeutic approaches, such as "watch and wait", where the aim is to treat some patients with definitive CRT alone. The success of these new approaches directly relies on the effectiveness of the radiotherapy (RT) treatment and thereby on the level as well as the accuracy of the delivered dose to the tumor.
Standard treatment today is based on a single set of CT- and MRI-scans, which are insufficient to estimate the organ motion during RT. Precise knowledge about the variation in position and shape of the tumor using multiple MRI scans before and during RT will have the potential to make future radiotherapy treatments more precise with less side effects.
The investigators will conduct a prospective study of sequential MRI scans before and during CRT. Patients will be MRI scanned six times in addition to the standard MRI-scan appointments and follow-up. This will provide a total of 9 MRI-scans of each patient; 3 before RT, 3 during RT and 3 during follow up. The information gained from these additional scans will provide a much better understanding of the tumor and organs during RT.
This project's overall focus is to make future RT treatments of rectal cancer patients as precise and efficient as possible. This could contribute to and aid the paradigm shift of making chemo-radiotherapy the main treatment strategy for some rectal cancer patients. This has the potential to spare patients of the severe morbidities associated with surgery, as well as the need for stomas.
- Keywords
- Effect of radiotherapy
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Use additional MRI scans before radiotherapy (for random changes) and during radiotherapy (for systematic changes). The organs at risk (OAR) 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.
Measured: 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.
Will be used to create an individual patient specific CTV-PTV margin.
Measured: Baseline, 3-4 days, an average of 9 days.
Change in treated volume using adaptive radiotherapy
An adaptive CTV-to-PTV margin will be calculated and the impact on the treated volume of PTV and OARs is assessed.
Measured: Baseline, an average of 7 days, an average of 14 days, average of 28 days
Change in the functional imaging parameter: ADC-value.
MRI scans providing morphological and functional data before, during and after CRT will provide information about treatment response and local toxicity. The ADC-value provided from the diffusion weighted imaging (DWI-) MRI scans will be analysed and compared to the morphological data. The change in the ADC value will be analysed and compared to RT dose plans. These will subsequently be compared to treatment-related adverse events as assessed by CTCAE v4.0 and patient reported outcome as assessed by LARS score and EORTC quality of life questionnaires (QLQ-C30 and QLQ-CR29).
Measured: 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.
MRI scans providing morphological and functional data before, during and after CRT will provide information about treatment response and local toxicity. The Ktrans-value provided from the dynamic contrast enhanced (DCE-) MRI scans will be analysed and compared to the morphological data. The change in the Ktrans-value will be analysed and compared to RT dose plans. These will subsequently be compared to treatment-related adverse events as assessed by CTCAE v4.0 and patient reported outcome as assessed by LARS score and EORTC quality of life questionnaires (QLQ-C30 and QLQ-CR29).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start29 Jun 2018
- Primary completion1 Feb 2022
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Tideman Arp, Aalborg University Hospital
- Investigators
- Dennis T. Arp, Medical Physicist, Principal investigator, Department of Medical Physics, Oncology, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619668
- Sponsor's protocol ID
- N-20170064
- Acronym
- AMPERE
- Status last verified
- Aug 2023
- First submitted
- 29 Jun 2018
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemo-radiotherapy as Main Treatment Strategy for Rectal Cancer. Can we Provide a More Precise and Effective Treatment
- ClinicalTrials.gov ID
- NCT03619668
- Acronym / sponsor ID
- AMPERE / N-20170064
- Keywords
- Effect of radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed with locally advanced adenocarcinoma of the rectum are treated with concomitant chemo-radiotherapy (CRT), with the aim of reducing local recurrences. Depending on tumor location, this is a pre-operative procedure prior to total mesorectal excision or partial mesorectal excision. The surgery is associated with a high risk of postoperative morbidity, however, especially when combined with CRT. Consequently, recent years have seen an increasing focus on other therapeutic approaches, such as "watch and wait", where the aim is to treat some patients with definitive CRT alone. The success of these new approaches directly relies on the effectiveness of the radiotherapy (RT) treatment and thereby on the level as well as the accuracy of the delivered dose to the tumor.
Standard treatment today is based on a single set of CT- and MRI-scans, which are insufficient to estimate the organ motion during RT. Precise knowledge about the variation in position and shape of the tumor using multiple MRI scans before and during RT will have the potential to make future radiotherapy treatments more precise with less side effects.
The investigators will conduct a prospective study of sequential MRI scans before and during CRT. Patients will be MRI scanned six times in addition to the standard MRI-scan appointments and follow-up. This will provide a total of 9 MRI-scans of each patient; 3 before RT, 3 during RT and 3 during follow up. The information gained from these additional scans will provide a much better understanding of the tumor and organs during RT.
This project's overall focus is to make future RT treatments of rectal cancer patients as precise and efficient as possible. This could contribute to and aid the paradigm shift of making chemo-radiotherapy the main treatment strategy for some rectal cancer patients. This has the potential to spare patients of the severe morbidities associated with surgery, as well as the need for stomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to standard chemoradiotherapy for locally advanced rectal cancer.
Key inclusion criteria (1 listed)
- All patients referred to standard chemoradiotherapy for locally advanced rectal cancer.
Key exclusion criteria (10 listed)
- Prior surgery in pelvic minor region
- Pacemaker
- Neurostimulator
- Other non MR-compatible implants
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in position and shape of the tumour during RT.
Time frame: Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days
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.
5 secondary outcomes
Changes in position and shape of organs during RT.
Time frame: 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.
Time frame: Baseline, 3-4 days, an average of 9 days.
Change in treated volume using adaptive radiotherapy
Time frame: Baseline, an average of 7 days, an average of 14 days, average of 28 days
Change in the functional imaging parameter: ADC-value.
Time frame: 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.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis T. Arp, Medical Physicist principal investigator
Department of Medical Physics, Oncology, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Rectal Adenocarcinoma, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in position and shape of the tumour during RT. (time frame: Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.