A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of high-dose radiation therapy on patients with locally advanced pancreatic cancer who have shown a positive response to initial chemotherapy. The main goal is to find out if this treatment can improve patient outcomes, such as enhancing quality of life and increasing survival rates. To participate, patients must have a confirmed diagnosis of locally advanced pancreatic cancer, have not had any cancer spread to other parts of the body, and must have completed at least 16 weeks of first-line chemotherapy without worsening of their condition.

Participants in the trial will receive high-dose radiation therapy and may also undergo a tumor biopsy. They will be asked to fill out questionnaires about their quality of life and provide blood samples for research. It’s important to note that the trial is not yet recruiting participants, and eligibility includes being between the ages of 65 and 74, with certain health criteria in place to ensure safety. This study aims to contribute valuable information that could help improve future treatments for pancreatic cancer.

Gender

ALL

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.