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

Locally Advanced Pancreatic Adenocarcinoma Clinical Trial

— ABLATE  

Official title:

Ablative Radiation Therapy With High Dose Geometric Boost for Locally Advanced Pancreatic Cancer Following Treatment Response Evaluation of Induction Chemotherapy: a Phase II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453486
• Other study ID #: OZUHN-031
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: April 2030

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Anna Dodd
• Phone: 647-539-6498
• Email: Anna.Dodd[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 a tumor biopsy.

• Undergo induction chemotherapy (chemotherapy given before radiation therapy) with modified FOLFIRINOX (FFX) or gemcitabine and nab-paclitaxel (GnP).

• If the participants disease remains stable or improves after chemotherapy, they will be treated with high dose radiation therapy (If the participants cancer progresses after chemotherapy, they will be treated by their doctor according to standard of care practices).

• Complete quality of life questionnaires.

• Donate research blood samples.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 47
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a histological or radiological 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.

• Have a tumour that is amenable to a core needle biopsy (percutaneous or EUS FNB).

• Be fit to safely undergo a tumour biopsy as judged by the investigator.

• Eastern Cooperative Oncology Group (ECOG) performance status =1 (Karnofsky =70%).

• Life expectancy of greater than 6 months, as judged by the investigator.

• Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.

• Be eligible to undergo systemic treatment with FFX or GnP.

• 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 with one or more contraindications to tumour biopsy.

• Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced stage 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.

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Adenocarcinoma

Intervention

Drug:
• Induction chemotherapy with modified FOLFIRINOX (FFX) or gemcitabine and nab-paclitaxel (GnP)
The study doctor will determine which of the two chemotherapy regimens a participant will receive: Modified FOLFIRINOX (FFX) is a combination of four drugs called oxaliplatin, leucovorin, irinotecan, and 5-fluorouracil. Drugs will be administered through a vein in the arm on the first day of each cycle. Each cycle lasts 14 days. Gemcitabine and nab-paclitaxel (GnP) will be administered through a vein in the arm on Day 1, 8, and 15 of each cycle. Each cycle lasts 28 days. In both cases, chemotherapy treatment will last 4 to 6 months.

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 day over 5 weeks. These numbers denote the total dose of radiation (in Gray, abbreviated as Gy) delivered over a specific number of fractions (abbreviated as Fx), and the respective time frames for administration. The selection of radiation therapy (RT) dose levels for participants is guided by the expertise and evaluation of the radiation oncologist.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	To evaluate the efficacy of ablative radiation therapy with high dose geometric boost for locally advanced pancreatic cancer following treatment response evaluation of induction chemotherapy, as measured by median overall survival (OS).	5 years