Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients
NCT02812992
Interventional
Phase 4
Active, not recruiting
GrantPax
The hypothesis of the proposed study is that individualized assessment directed treatment
algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine
therapy. The project uses a CGA, which includes various tests and scoring systems, to
stratify patients as "GO-GO", "SLOW-GO" or "FRAIL" patients. Depending on test results
patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group:
gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of
chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign
patients to their definite treatment arm. The primary objective is that CGA-stratified
patients do not decline in their CGA performance in response to chemotherapy measured as a
loss of five points or less in the Barthel's ADL (ADL1 vs. ADL2 during core CGA assessment).
Jun 30,2016
All
70 Years
N/A
70 Years
N/A
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