STARPAC2
Research type
Research Study
Full title
Phase IIb randomised clinical trial repurposing ATRA as a stromal targeting agent in a novel drug combination for pancreatic cancer
IRAS ID
1003111
Contact name
Hemant Kocher
Contact email
Eudract number
2019-004231-23
Clinicaltrials.gov Identifier
Research summary
Pancreatic cancer (PDAC) is the fourth highest cancer killer worldwide and is
responsible for 6% of cancer deaths. Around 80% of patients are diagnosed at a late
stage when cancer has spread and surgical removal is no longer possible. Most patients
appear with advanced disease, with approximately 35% of patients having locally
advanced (laPDAC), for which the current treatment options are minimally effective.
The study will run at secondary care NHS sites. Patients will be randomised to receive
gemcitabine + nab-paclitaxel or gemcitabine + nab-paclitaxel + ATRA. ATRA (if
allocated), gemcitabine and nab-paclitaxel will be administered in 28 day cycles. ATRA
will be administered for 6 cycles whereas gemcitabine/nab-paclitaxel will be
administered until the disease worsens, and all patients will be followed up until death,
loss to follow up or study termination.
Eligible patients will be identified through Precision-Panc, a national initiative for
pancreatic cancer funded by CRUK, or in the normal NHS setting when undergoing
exploratory surgery for their pancreatic cancer.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0136
Date of REC Opinion
29 May 2020
REC opinion
Further Information Favourable Opinion