Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06453486

Ablative Radiation Therapy With High Dose Geometric Boost for Locally Advanced Pancreatic Cancer Patients After Response to Standard Chemotherapy

Led by University Health Network, Toronto · Updated on 2026-04-16

43

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of high-dose radiation therapy in patients with locally advanced pancreatic cancer who have responded to initial chemotherapy. This Phase II clinical trial aims to determine whether this radiation treatment can improve outcomes, quality of life, or overall survival rates for these patients. The study is sponsored by the University Health Network, Toronto, and focuses on patients whose cancer has remained stable or decreased in size after chemotherapy. Participants will receive high-dose radiation therapy delivered in fractions over set periods, such as 50 Gray over 5 sessions every other day in 2 weeks, 67.5 Gray over 15 sessions daily in 3 weeks, or 75 Gray over 25 sessions daily in 5 weeks. The specific radiation dose and schedule will be determined by the radiation oncologist based on each participant's condition. An optional tumor biopsy may be performed before treatment. During the study, participants will complete quality of life questionnaires and donate blood samples for research. Researchers will monitor overall survival over 5 years as the primary outcome. Participants must be able to give informed consent and will be followed closely to assess treatment effects and safety. The study will begin in March 2025 and continue through April 2030.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a histological or cytological diagnosis of locally advanced pancreatic cancer (LAPC)
  • Pancreatic tumor less than 8.0 cm in greatest axial dimension at treatment planning, meeting radiation tissue constraints
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less (Karnofsky score 70% or higher)
  • Life expectancy greater than 6 months as judged by the investigator
  • Completed at least 16 weeks of first-line chemotherapy for this cancer without progression
  • At least 2 weeks since last chemotherapy before starting trial therapy
  • Able to understand and willing to sign informed consent
  • Women must not be pregnant or breastfeeding and must have a negative pregnancy test within 4 weeks before registration
  • Breastfeeding women must stop breastfeeding before registration
Not Eligible

You will not qualify if you...

  • Metastatic disease at registration
  • Age under 18 years
  • Prior systemic treatment in metastatic setting
  • Prior radiotherapy to upper abdomen overlapping current radiation area
  • Currently receiving any anti-cancer treatment including chemotherapy
  • Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Pregnant or breastfeeding women
  • Other conditions contraindicating safe participation as judged by investigator
  • History of other malignancy unless disease-free for at least 2 years and low risk of recurrence; exceptions include cervical cancer in situ and certain skin cancers diagnosed in past 5 years
  • Diseases preventing high dose radiation such as scleroderma or ulcers within treatment area
  • Contraindications for MRI including pacemaker, metallic foreign bodies, severe claustrophobia, prior anaphylaxis to gadolinium, or severe kidney disease (glomerular filtration rate below 30 mL/min/1.73m2) or acute kidney disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 to 5 weeks depending on radiation schedule

Participants receive high dose radiation therapy delivered in fractions over a set period to target and treat the tumor. The radiation dose and schedule are determined by the radiation oncologist and may be administered every other day over 2 weeks or once daily over 3 to 5 weeks.

Daily or every other day visits during treatment (5 to 25 sessions)

Trial Site Locations

Total: 2 locations

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

2

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

A

Anna Dodd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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