Locally Advanced Pancreatic Adenocarcinoma study: High dose radiation therapy
Official title A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment
ClinicalTrials.gov ID: NCT06453486
What this study is testing
- What it's testing
- The study wants to see if adding high‑dose radiation therapy after chemotherapy improves outcomes, quality of life, or survival for these patients.
- Who it's for
- Adults with locally advanced pancreatic cancer whose tumors stayed the same size or got smaller after initial chemotherapy.
- What's involved
- Participants may have a tumor biopsy, receive high‑dose radiation therapy, fill out quality‑of‑life questionnaires, and give blood samples for research.
- Time commitment
- The trial lasts for the radiation treatment period and includes follow‑up visits for questionnaires and blood draws.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
- 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...
- 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 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.