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RecruitingLast updated: 31 January 2024

MASTERPLAN: This phase II trial is evaluating the effectiveness and safety of chemotherapy (Mfolfirinox) and stereotactic radiotherapy in people with locally advanced 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 participants will be randomised on a 2:1 basis based on minimisation and stratification by tumour stage, planned chemotherapy and institution, to one of two arms. Participants in the Experimental Arm will receive chemotherapy (12 week of mFOLFIRINOX and/or 12 additional weeks of gemcitabine/capecitabine), followed by radiation therapy (SBRT) to commence within 3 weeks of completing initial chemotherapy (40 Gray [GY] in 5 fractions over 2 weeks). Eligible participants will receive surgery 6 weeks post-completion of initial surgery. Patients who are not eligible for surgery will continue ongoing chemotherapy. Participants in the Active Comparator Arm will receive chemotherapy (12 weeks of mFOLFIRINOX or 12 additional weeks of gemcitabine/capecitabine). Eligible participants will receive surgery 6 weeks post-completion of initial surgery. Patients who are not eligible for surgery will continue ongoing chemotherapy.

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

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 histological confirmation of pancreatic adenocarcinoma

  • Any of the following

    1. T3 (tumour >4 cm)
    2. Extrapancreatic extension
    3. Node positive (stage IIB)
    4. 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 <1.5 X ULN (Upper Limit of Normal), AST + ALT <3.0 X ULN. In patients who have had a recent biliary drainage and whose bilirubin is descending, a value of ≤ 3 X N is acceptable
  • Study treatment planned to start within 14 days of registration
  • 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
  • Prior abdominal radiotherapy
  • 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, or any Stage 1 endometrial carcinoma. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary 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 registration. 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

Inclusion

  • Your cancer has not spread to other parts of the body.

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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