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RecruitingLast updated: 12 February 2024

MASTERPLAN: This phase II trial is trying to understand whether adding high precision radiotherapy to chemotherapy and surgery will improve treatment outcomes for patients with pancreatic cancerA Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

Clinical summary

Summary

Eligible patients will be randomised into one of two groups; both of which will undergo a chemotherapy regimen, containing either a mFOLFIRINOX or Gemcitabine/Nab-paclitaxel drug combination. Only one group will go on to receive stereotactic radiotherapy, before potentially undergoing surgery.

Conditions

This trial is treating patients with pancreatic cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 75

Phase

II

Trial Acronym

MASTERPLAN

More information

Trial Identifiers

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Trial sponsor

Australian Government Department of Health, Medical Research Future Fund (MRFF), Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

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

Eligibility

Inclusion

 

*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

. 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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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