MASTERPLAN

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Trial Status

In activation

Cancer Type

Pancreatic cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

AIM

Pancreatic cancer (PC) has the fifth highest incidence of cancer related mortality and accounts for the death of more than 2900 Australians annually.Approximately half of PC patients experience a recurrence of their cancer within or around the pancreas within the first 12 months. Even in those patients who are able to undergo resection, 40% fail loco regionally in the first 12 months.

Stereotactic body radiotherapy (SBRT) is a highly innovative treatment that utilises the significant technological advancements in radiotherapy treatment. SBRT enables safe radiotherapy dose escalation that increases tumour cell death, while minimising dose and toxicity to surrounding normal tissues. Additionally, SBRT may reduce the significant morbidity of recurrent loco regional disease including pain, bleeding and gastric outlet obstruction.

SUMMARY

MASTERPLAN investigates whether SBRT in addition to modern chemotherapy is superior to the current standard of chemotherapy alone in both the neoadjuvant and definitive setting. An important component of MASTERPLAN is to incorporate high quality tissue collection to facilitate future molecular and genetic research. MASTERPLAN is a major multidisciplinary collaboration of Australia’s leading pancreatic clinicians and scientists in the context of a multicentre phase II trial sponsored by AGITG, conducted by NHMRC Clinical Trials Centre, and done in collaboration with the Trans Tasman Radiation Oncology Group (TROG).

Trial Status

In Activation

Cancer Type

Pancreatic cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Aim

To determine if the addition of stereotactic body radiotherapy (SBRT) to chemotherapy improves locoregional control for patients with high-risk operable, borderline resectable (BRPC) and locally advanced prostate cancer (LAPC).

Background

The five year overall survival for patients with pancreatic cancer (PC) is 8%. Patients with PC have inferior survival to patients with breast, prostate, cervical, bladder, colorectal, stomach, oesophagus, lung, kidney, liver and brain cancer. PC has the fifth highest incidence of cancer related mortality and accounts for the death of more than 2,900 Australians annually. For the 80% of PC patients with non-metastatic PC who have high-risk, borderline resectable (BRPC) or locally advanced pancreas cancer (LAPC), the 5-year overall survival is abysmal, at 12%. This is despite having no demonstrable metastatic disease at diagnosis. Approximately half of all PC patients experience locoregional recurrence (LRR). Even with surgery, 40% of patients will experience a LRR in the first 12 months [5]. LRR is the most common site of treatment failure for patients with PC and this is a major contributor to the substantial morbidity and mortality of this cancer. Clinical trials exploring new treatment paradigms for PC including stereotactic body radiotherapy (SBRT), molecular targets and novel biomarkers are recommended within international consensus guidelines. SBRT is a significant dose escalation to standard external beam radiotherapy (EBRT) without an increase in toxicity. This is anticipated to increase tumour cell kill and reduce rates of LRR. Reduced LRR rates could increase the likelihood of R0 resection allowing the possibility of cure, reduce the debilitating symptoms associated with LRR and progression, and potentially improve overall survival by preventing or delaying development of metastases. LRR is associated with significant pain and suffering due to gastric outlet obstruction, duodenal erosion and coeliac plexus infiltration, and ultimately results in premature death.

Clinical Trial Design

A multicentre randomised phase II study comparing SBRT with modern chemotherapy to modern chemotherapy alone for high-risk operable, borderline resectable and locally advanced pancreas cancer (n=120).

Key Eligibility Criteria

Inclusion Criteria:

  •  T3 (tumour >4 cm), extrapancreatic extension, node positive (Stage IIB), borderline
    resectable, or locally advanced pancreatic cancer with histologic or cytologic confirmation
  • Measurable disease as defined by RECIST 1.1
  • Age ≥18 years, ECOG performance status 0–2.
  • Suitability for chemotherapy with mFOLFIRINOX (or other oxaliplatin based), or
    gemcitabine +/- nab-paclitaxel
  • Able to give informed consent

Exclusion Criteria:

  • Metastatic pancreatic cancer
  • Clearly operable pancreatic cancer <4cm
  • Prior abdominal radiotherapy
  • Active malignancy, excluding non-melanomatous skin cancer
  • Neuroendocrine pancreatic carcinoma
  • Pregnant or lactating women

Principal Investigator

Dr Andrew Oar

A/Prof Andrew Kneebone