Comparator supply for NCT04340141
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
Sponsor: Alliance for Clinical Trials in Oncology (OTHER). Phase: PHASE3. Status: Active Not Recruiting. Countries: United States, Canada. Last update posted 2026-09-04.
Registry record: https://clinicaltrials.gov/study/NCT04340141.
Canadian-labelled fluorouracil
5 marketed Canadian product(s) from 4 manufacturer(s) contain fluorouracil. Available strengths: 0.5 G / 10 ML, 5 %, 5 G / 100 ML, 50 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled irinotecan hydrochloride
6 marketed Canadian product(s) from 4 manufacturer(s) contain irinotecan hydrochloride. Available strengths: 100 MG / 5 ML, 20 MG, 500 MG / 25 ML. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled oxaliplatin
5 marketed Canadian product(s) from 5 manufacturer(s) contain oxaliplatin. Available strengths: 5 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
What we supply
- Canadian-labelled comparator sourced through licensed Canadian supply
- Certificate of Analysis for every batch
- Batch number and expiry documentation, with retained records
- Blinding-ready packaging and over-encapsulation on request
- 2–8 °C validated cold chain with temperature logging where required
- Health Canada Drug Establishment Licence #3-002896
Frequently asked questions
Can Nexara supply Canadian-labelled fluorouracil as a trial comparator?
Yes. We source Canadian-marketed fluorouracil under Health Canada Drug Establishment Licence #3-002896 and ship it with Certificate of Analysis, batch number and expiry documentation for use as a comparator or rescue supply in NCT04340141.
What documentation comes with each shipment?
Certificate of Analysis, manufacturer batch and expiry records, chain-of-custody documentation from the Canadian supply chain, and temperature records where cold chain applies. Blinding-ready packaging is available on request.
How long does comparator supply take?
Quotes are returned within one business day. Lead time depends on the presentation and the destination country's import route — typically 10 to 21 days once the importer's licence and any notification are in place.
Request comparator quote
Request comparator quote or call +1-431-588-9055.