Clinical trialPhase 2Terminated
PRIMUS002: Looking at 2 Neo-adjuvant Treatment Regimens for Resectable and Borderline Resectable Pancreatic Cancer
PRIMUS002: An Umbrella Phase II Study Examining Two Neo-adjuvant Regimens (FOLFOX-A and AG) in Resectable and Borderline Resectable Pancreatic Ductal AdenoCarcinoma (PDAC), Focusing on Biomarker and Liquid Biopsy Development
- Outcome
- Stopped earlyDue to funding being withdrawn (Business decision)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 5 March 2019
- Expected end
- 19 August 2021
- Enrollment
- 31 participants
- Sites
- 3
- Primary outcomes
- Time to progression post FOLFOX-A induction treatment
- Sponsor
- Other
- Results posted
- No
- Last update
- 24 May 2022
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Brief summary public domain (ClinicalTrials.gov)
PRIMUS 002 is looking at 2 different chemotherapy regimens in the neo-adjuvant setting for pancreatic cancer. Each treatment will be given for 3 months prior to surgery
Detailed description public domain (ClinicalTrials.gov)
This is an integrated, open label, non-randomised, phase II trial of 2 neo-adjuvant regimens (FOLFOX-A and AG) assessing efficacy and toxicity with integrated translational work. The study is powered on testing a proposed DNA damage response deficient biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG are recruited concurrently. The study has a prospective safety assessment of neo-adjuvant chemotherapy and neo-adjuvant chemotherapy followed by chemoradiotherapy consisting of conventional radiotherapy with concomitant capecitabine. This safety assessment will include all patients (FOLFOX-A and AG)