Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients
- Conditions
- Adenocarcinoma Pancreas
- Interventions
- Registration Number
- NCT02812992
- Lead Sponsor
- AIO-Studien-gGmbH
- Brief 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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GO-GO arm Nab-paclitaxel Nab-paclitaxel 125 mg/m\^2 i.v. over 30 minutes followed by gemcitabine infusion 1000 mg/m\^2 on days D1, D8, D15 of a 28-day cycle. FRAIL arm Best Supportive Care Best supportive care as determined by the investigator. SLOW-GO arm Gemcitabine Gemcitabine 1000 mg/m\^2 i.v. on days D1, D8, D15 of a 28-day cycle. GO-GO arm Gemcitabine Nab-paclitaxel 125 mg/m\^2 i.v. over 30 minutes followed by gemcitabine infusion 1000 mg/m\^2 on days D1, D8, D15 of a 28-day cycle.
- Primary Outcome Measures
Name Time Method Barthel's ADL [Barthel's scale in activities of daily living] 4 weeks Loss of five points or less in the Activity of Daily Living (Barthel's ADL; assessed during 2nd CGA) after first cycle of chemotherapy (or after 4 weeks in BSC group) compared to the initial ADL for each treatment groups.
- Secondary Outcome Measures
Name Time Method Discrepancy between CGA strata estimation by the investigator and true CGA assessment 12 months ADL (Barthel) [Activities of Daily Living] 4 weeks Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
IADL (Lawton/Browdy) [Instrumental Activities of Daily Living] 4 weeks Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
G8-Questionnaire 4 weeks Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
Percentage of patients receiving at least one chemotherapy in each treatment group 12 months Duration of treatment 12 months Cumulative dose 12 months QoL [Quality of Life] 12 months time to QoL deterioration \[loss of 10 points or more in QLQ-C30\]
ECOG [Eastern Cooperative Oncology Group] 4 weeks Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
AEs/SAEs [Adverse Events/Serious Adverse Events] 12 months PFS [Progression Free Survival] 12 months OS [Overall Survival] 12 months CR [Complete Response] 12 months DCR [Disease Control Rate] 12 months PR [Partial Response] 12 months ORR [Objective Response Rate] 12 months Percentage of patients escalating treatment 12 months CGA [Comprehensive Geriatric Assessment] 4 weeks Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC
Trial Locations
- Locations (1)
Universitätsklinikum Mannheim II. Medizinische Klinik
🇩🇪Mannheim, Germany