Testing High dose radiation therapy for locally advanced pancreatic adenocarcinoma
Official title: A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment
Ablative Radiation Therapy With High Dose Geometric Boost for Locally Advanced Pancreatic Cancer Patients Following Treatment Response Evaluation of Standard of Care Induction Chemotherapy (ABLATE): a Phase II Clinical Trial
Interventions
High dose radiation therapy
High dose radiation refers to the administration of a concentrated beam of radiation to target and treat the tumor. High dose radiation therapy typically involves delivering radiation in fractions over a set period. For instance, options such as: * 50Gy/5Fx: 50 Gray delivered over 5 fractions, administered every other day over 2 weeks. * 67.5Gy/15Fx: 67.5 Gray delivered over 15 fractions, administered once a day over 3 weeks. * 75Gy/25Fx: 75 Gray delivered over 25 fractions, administered once a day over 5 weeks. These numbers denote the total dose of radiation (in Gray, abbreviated as Gy) delivered over a specific number of fractions (abbreviated as Fx), and the respective time frames for administration. The selection of radiation therapy (RT) dose levels for participants is guided by the expertise and evaluation of the radiation oncologist.
Canadian Sites (2)
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Have a histological or cytological diagnosis of LAPC.
- +Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Karnofsky ≥70%).
- +Life expectancy of greater than 6 months, as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +Ability to understand and willing to sign a written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → document.
- +Women must not be pregnant or breast-feeding. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should discontinue breastfeeding prior to study registration.
- +Have pancreatic tumour \<8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → will be based upon satisfying the radiation normal tissue constraints.
- +Patients must have had prior first-line chemotherapy for this cancer for at least 16 weeks without clinical or radiographic progression. There should be a washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → of at least 2 weeks from first-line chemotherapy and start of therapy on clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
Exclusion
- −Patient should NOT be treated with MR-Linac if they have any contraindications for MRI, including presence of a heart pacemaker, (ferrous) metallic foreign bodies, and severe claustrophobia. Patients will be screenedScreeningThe checks done before joining, to see whether a study fits.Read more → and excluded from the study if they have previous anaphylactic reactions to gadolinium and severe kidney disease (glomerular filtration rate \< 30mL/min/1.73m2) or acute kidney disease.
- −Metastatic disease at the time of registration
- −Prior radiotherapy to the upper abdomen region that would result in overlap of RT volume for the current study.
- −Uncontrolled inter-current illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- −Any other condition that would, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- −Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- −Individuals with diseases precluding high dose ablative RT (e.g. scleroderma, gastric or bowel ulceration or perforation within the planned irradiated volume)
- −Pregnant and breastfeeding women.
- −Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the metastatic setting.
- −Patients who are currently on anti-cancer treatment including chemotherapy.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: High dose radiation therapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 43 people.
The study is currently expected to finish around April 2030.
The main measurement is taken over: 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall survival (OS) — measured over 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06453486 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About High dose radiation therapyRadiation
High dose radiation refers to the administration of a concentrated beam of radiation to target and treat the tumor. High dose radiation therapy typically involves delivering radiation in fractions over a set period. For instance, options such as: * 50Gy/5Fx: 50 Gray delivered over 5 fractions, administered every other day over 2 weeks. * 67.5Gy/15Fx: 67.5 Gray delivered over 15 fractions, administered once a day over 3 weeks. * 75Gy/25Fx: 75 Gray delivered over 25 fractions, administered once a day over 5 weeks. These numbers denote the total dose of radiation (in Gray, abbreviated as Gy) delivered over a specific number of fractions (abbreviated as Fx), and the respective time frames for administration. The selection of radiation therapy (RT) dose levels for participants is guided by the expertise and evaluation of the radiation oncologist.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 5 years.
The study as a whole is currently expected to finish around 2030-04.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 43 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to test the effect of high-dose radiation therapy after initial chemotherapy in patients with locally advanced pancreatic cancer. The main question it aims to answer is: • For patients with locally advanced pancreatic cancer that responded to initial chemotherapy (stayed stable or decreased in size), will high-dose RT (radiation therapy) contribute to improving treatment outcomes, enhancing quality of life, or increasing overall survival rates? Participants will: * Undergo an optional tumor biopsy. * Be treated with high dose radiation therapy. * Complete quality of life questionnaires. * Donate research blood samples.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.