A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High dose radiation therapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Radiation 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
Primary outcome measures
- Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Have a histological or cytological diagnosis of LAPC.
- Have pancreatic tumour <8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibility will be based upon satisfying the radiation normal tissue constraints.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Karnofsky ≥70%).
- Life expectancy of greater than 6 months, as judged by the investigator.
- 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 washout of at least 2 weeks from first-line chemotherapy and start of therapy on clinical trial.
- Ability to understand and willing to sign a written informed consent 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.
Exclusion criteria
- Metastatic disease at the time of registration
- Age<18.
- Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the metastatic setting.
- Prior radiotherapy to the upper abdomen region that would result in overlap of RT volume for the current study.
- Patients who are currently on anti-cancer treatment including chemotherapy.
- 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.
- Pregnant and breastfeeding women.
- Any other condition that would, in the investigator'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)
- 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 screened 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Princess Margaret Cancer Centre — Toronto
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT06453486 · OZUHN-031