A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease (MASTERPLAN)

Australasian Gastro-Intestinal Trials Groups (AGITG)0 sites120 target enrollmentMarch 13, 2019

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Australasian Gastro-Intestinal Trials Groups (AGITG)
Enrollment: 120
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 13, 2019

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Australasian Gastro-Intestinal Trials Groups (AGITG)

Eligibility Criteria

Inclusion Criteria

•\*Adults, aged between 18\-75 years, with pathologic confirmation of pancreatic adenocarcinoma
•\*Patients who are treatment\-naïve, or have been commenced on chemotherapy less than or equal to 28 days prior to randomisation.
•\*Any of the following: T3 (tumour greater than 4 cm), Extrapancreatic extension, Node positive , Borderline resectable pancreatic cancer, locally advanced pancreatic cancer
•\*Measurable disease according to RECIST v1\.1
•\*ECOG performance status 0\-1
•\*Adequate renal and haematological function
•\*Adequate hepatic function. Defined as bilirubin less than 1\.5 X ULN (Upper Limit of Normal), AST \+ ALT less than 3\.0 X ULN. If a patient was recently stented with improving bilirubin, the patient can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.
•\*Study treatment planned to start within 14 days of randomisation
•\*Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
•\*Signed, written informed consent

Exclusion Criteria

•. Tumour size greater than 70mm
•. Duodenal infiltration seen on endoscopy
•. Prior abdominal radiotherapy,or previous radiation where the 5 Gy isodose line crosses into the treatment field (or an approximation of this if axial based imaging not utilised).
•. Evidence of metastatic disease on baseline radiologic investigations
•. History of another malignancy within 2 years prior to randomisation, except adequately treated carcinoma\-in\-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, \-superficial transitional cell carcinoma of the bladder, any Stage 1 endometrial carcinoma, low risk prostate cancer with PSA less than or equal to 10 and Gleason score of less than or equal to 6 treated with any modality, including active surveillance\-Patients with treated early\-stage breast cancer on adjuvant endocrine therapy are eligible provided they have been disease free for at least 2 years after definitive treatment. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive treatment.
•. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
•. Neuroendocrine pancreatic carcinoma
•. Life expectancy of less than 3 months
•. Pregnancy, lactation, or inadequate contraception. Women must be post\-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception
•. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol