drugset / Trial / NCT02812992

Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients

NCT02812992

Phase 4 Completed 32 enrolled AIO-Studien-gGmbH
RandomizedParallel-groupOpen-labelTreatment

Summary

The GrantPax study is a multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients. 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).

Timeline

Start
2016-06
Primary completion
2020-02
Completion
2021-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 125 mg/m2 Intravenous