High-dose radiation therapy for advanced pancreatic cancer after chemotherapy

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

This study tests whether high-dose radiation therapy can help people with advanced pancreatic cancer who responded well to chemotherapy feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT06453486 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of high-dose radiation therapy in patients with locally advanced pancreatic cancer who have shown a positive response to initial chemotherapy. Participants will receive high-dose radiation treatment and may undergo an optional tumor biopsy, complete quality of life questionnaires, and donate blood samples for research. The study seeks to determine if this approach can improve treatment outcomes, enhance quality of life, or increase overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are patients with locally advanced pancreatic adenocarcinoma who have responded to initial chemotherapy and meet specific eligibility criteria.

Not a fit: Patients with pancreatic tumors larger than 8.0 cm or those who have not responded to initial chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced pancreatic cancer.

How similar studies have performed: While this approach is being tested, similar studies have shown promise in improving outcomes for patients with advanced cancers using high-dose radiation therapy.

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.

Where this trial is running

Toronto, Ontario and 1 other locations

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
• McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Erica Tsang, MD — University Health Network, Toronto
• Study coordinator: Anna Dodd

Conditions Locally Advanced Pancreatic Adenocarcinoma