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AGITG MASTERPLAN: a randomised phase II study of modified FOLFIRINOX alone or in combination with stereotactic body radiotherapy for patients with high-risk and locally advanced pancreatic cancer

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العنوان: AGITG MASTERPLAN: a randomised phase II study of modified FOLFIRINOX alone or in combination with stereotactic body radiotherapy for patients with high-risk and locally advanced pancreatic cancer
المؤلفون: Nam Q. Nguyen, Jaswinder S. Samra, Julie Chu, Andrew Oar, Andrew Kneebone, Hien Le, Katrin Marie Sjoquist, Kate Wilson, Val Gebski, Andrew Barbour, John Simes, Alisha Moore, Chris Aiken, David Goldstein, David Espinoza, Mark T Lee, Sonia Yip, Lorraine A. Chantrill
المصدر: BMC Cancer, Vol 21, Iss 1, Pp 1-11 (2021)
BMC Cancer
بيانات النشر: Springer Science and Business Media LLC, 2021.
سنة النشر: 2021
مصطلحات موضوعية: Male, Cancer Research, FOLFIRINOX, Leucovorin, Phases of clinical research, Study Protocol, Antineoplastic Combined Chemotherapy Protocols, Stereotactic radiotherapy, Multicenter Studies as Topic, Prospective Studies, RC254-282, Randomized Controlled Trials as Topic, SBRT, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Middle Aged, Prognosis, Combined Modality Therapy, Oxaliplatin, mFOLFIRINOX, Oncology, Female, Fluorouracil, Radiology, Modified FOLFIRINOX, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Nab-paclitaxel, Irinotecan, Radiosurgery, Borderline resectable, Young Adult, Clinical Trials, Phase II as Topic, Pancreatic cancer, Genetics, medicine, Humans, Pancreas, Aged, business.industry, Induction chemotherapy, medicine.disease, Interim analysis, Gemcitabine, Pancreatic Neoplasms, business, Follow-Up Studies
الوصف: Background Among patients with non-metastatic pancreatic cancer, 80% have high-risk, borderline resectable or locally advanced cancer, with a 5-year overall survival of 12%. MASTERPLAN evaluates the safety and activity of stereotactic body radiotherapy (SBRT) in addition to chemotherapy in these patients. Methods and design MASTERPLAN is a multi-centre randomised phase II trial of 120 patients with histologically confirmed potentially operable pancreatic cancer (POPC) or inoperable pancreatic cancer (IPC). POPC includes patients with borderline resectable or high-risk tumours; IPC is defined as locally advanced or medically inoperable pancreatic cancer. Randomisation is 2:1 to chemotherapy + SBRT (investigational arm) or chemotherapy alone (control arm) by minimisation and stratified by patient cohort (POPC v IPC), planned induction chemotherapy and institution. Chemotherapy can have been commenced ≤28 days prior to randomisation. Both arms receive 6 × 2 weekly cycles of modified FOLFIRINOX (oxaliplatin (85 mg/m2 IV), irinotecan (150 mg/m2), 5-fluorouracil (2400 mg/m2 CIV), leucovorin (50 mg IV bolus)) plus SBRT in the investigational arm. Gemcitabine+nab-paclitaxel is permitted for patients unsuitable for mFOLFIRINOX. SBRT is 40Gy in five fractions with planning quality assurance to occur in real time. Following initial chemotherapy ± SBRT, resectability will be evaluated. For resected patients, adjuvant chemotherapy is six cycles of mFOLFIRINOX. Where gemcitabine+nab-paclitaxel was used initially, the adjuvant treatment is 12 weeks of gemcitabine and capecitabine or mFOLFIRINOX. Unresectable or medically inoperable patients with stable/responding disease will continue with a further six cycles of mFOLFIRINOX or three cycles of gemcitabine+nab-paclitaxel, whatever was used initially. The primary endpoint is 12-month locoregional control. Secondary endpoints are safety, surgical morbidity and mortality, radiological response rates, progression-free survival, pathological response rates, surgical resection rates, R0 resection rate, quality of life, deterioration-free survival and overall survival. Tertiary/correlative objectives are radiological measures of nutrition and sarcopenia, and serial tissue, blood and microbiome samples to be assessed for associations between clinical endpoints and potential predictive/prognostic biomarkers. Interim analysis will review rates of locoregional recurrence, distant failure and death after 40 patients complete 12 months follow-up. Fifteen Australian and New Zealand sites will recruit over a 4-year period, with minimum follow-up period of 12 months. Discussion MASTERPLAN evaluates SBRT in both resectable and unresectable patients with pancreatic ductal adenocarcinoma. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12619000409178, 13/03/2019. Protocol version: 2.0, 19 May 2019
تدمد: 1471-2407
1261-9000
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f907deffc641681cae98b2e65bd8e75c
https://doi.org/10.1186/s12885-021-08666-y
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....f907deffc641681cae98b2e65bd8e75c
قاعدة البيانات: OpenAIRE
الوصف
تدمد:14712407
12619000