A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients (GrantPax)

Date

08 Oct 2016

Session

Poster Display

Presenters

Nicolai Härtel

Citation

Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371

Authors

N. Härtel1, J. Chi-Kern1, J. Betge1, S. Belle1, N. Schulte1, M. Maenz2, U. Wedding3, M. Ebert1

Author affiliations

  • 1 Ii. Med. Klinik, Universitätsklinikum Mannheim, 68167 Mannheim - Mannheim/DE
  • 2 Clinical Research, AIO-Studien-gGmbH, 14057 - Berlin/DE
  • 3 Department Of Medicine Ii, Universitätsklinikum Jena, 07743 - Jena/DE
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Resources

Background

Recent studies demonstrated that nab-paclitaxel/gemcitabine “nab/gem” is an effective 1st line regimen for metastatic pancreatic ductal adenocarcinomas “mPDAC”. There is clinical evidence indicating “nab/gem” not to be feasible in mPDAC pts ≥75 yrs. However the analyzed patients lacked a geriatric assessment to properly evaluate their functional reserve. The aim of this study is to determine whether comprehensive geriatric assessments “CGAs” can predict the benefit from combined nab/gem therapy for elderly mPDAC pts in 1st line. A stratified treatment approach shall result in patient groups with a stable or improving CGA performance during the 1rst cycle of treatment.

Trial design

Grantpax is a multicenter, open label phase 4 interventional trial with stratified parallel treatment groups (n = 45 / treatment arm). The hypothesis is that individualized assessment directed treatment algorithms identify elderly pts (≥70 yrs), who benefit from combined nab/gem therapy. The project uses a CGA to stratify pts as GOGO, SLOWGO or FRAIL. Depending on test results pts receive chemotherapy (GOGO: nab/gem; SLOWGO: gemcitabine) or best supportive care (FRAIL). After 1st cycle of chemotherapy (4 wks) a subsequent CGA and a safety assessment will be performed to assign pts to their definite treatment arm. The primary objective is that CGA-stratified pts do not decline in their CGA performance in response to chemotherapy measured as a loss of 5 points or less in Barthel's activities of daily living (ADL1 vs. ADL2 during CGA core assessment). The expected proportion of pts with ADL decline in each treatment group is 6%. Under this assumption it shall be shown with 80% power at 1-sided significance level α of 0.05 that the proportion of pts with functional decline is less than 20% (n = 43 / group; ADL decline: n = 2 / group). Secondary endpoints are CGA scores during the course of therapy (CGA1-4), response rates, safety, survival rates, duration of treatment, cumulative dose, quality of life and discrepancy between CGA strata estimation by the investigator and true CGA assessment. Grantpax is the first trial that realizes a CGA-driven treatment approach to individualize cancer therapy for elderly pts.

Clinical trial identification

AIO-GER-0115; EudraCT-No.: 2015-002890-40

Legal entity responsible for the study

This Abstract have not been presented until now.

Funding

Celgene Corporation

Disclosure

N. Härtel: This investigator initiated trial is funded by the Celgene Coporation. Dr. Nicolai Haertel participated at advisory boards organized by the Celgene Corporation (presentation incl.). There are no further conflicts of interest to declare.

M. Ebert: This investigator initiated trial is funded by the Celgene Coporation. Dr. Nicolai Haertel participated at advisory boards organized by the Celgene Corporation. There are no further conflicts of interest to declare.

All other authors have declared no conflicts of interest.

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