Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT02812992
Eligibility Criteria:
Inclusion Criteria 1 - Chemotherapy arms (Go-Go, Slow-Go):
1. Patients ≥ 70 years of age.
2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
3. At least one measurable lesion of disease according to RECIST 1.1 criteria.
4. No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least \> 6 months prior enrollment).
5. Adequate end organ function:
* renal function: serum creatinine ≤ 1.5 x ULN or GFR ≥ 30mL/min.
* hematopoietic function: white blood cell (WBC) count ≥3000/μL, absolute neutrophil count (ANC) ≥ 1500/μL, platelets ≥10\^5/μL, hemoglobin level \>9.0 g/dL
* liver function: total bilirubin ≤1.5 x ULN, AST / ALT ≤3.0 x ULN
6. Cooperation and willingness to complete all aspects of the study
7. Written informed consent to participate in the study
Inclusion criteria 2 - FRAIL arm:
1. Patients ≥ 70 years of age.
2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
3. No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least \> 6 months prior enrollment).
4. Cooperation and willingness to complete all aspects of the study
5. Written informed consent to participate in the study
Exclusion Criteria 1 - Chemotherapy arms (Go-Go, Slow-Go):
1. Patients \<70 years of age.
2. Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
3. Patient has a severe and/or uncontrolled medical disease (i.e. uncontrolled active infection, uncontrolled hypertension/ diabetes or cardiac disease).
4. Patient has received any other investigational product within 28 days prior study entry.
5. Patient is \< 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
6. Hypersensitivity against gemcitabine or nab-paclitaxel.
7. Major surgery ≤ 28 days prior to study entry.
8. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
9. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
10. Any other chemotherapy at start.
11. Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
12. Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes of a study medication, whichever is of longer duration, prior study start.
13. Patient has already been recruited in this trial.
14. Patients who do not understand the nature, the scope and the consequences of the clinical trial.
15. Patient who might be dependent on the sponsor, the study site or the investigator.
16. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 Nr. 4 AMG.
Exclusion criteria 2 - FRAIL arm:
1. Patients \<70 years of age.
2. Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
3. Patient has received any other investigational product within 28 days prior study entry.
4. Patient is \< 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
5. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
6. Any chemotherapy at study start.
7. Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
8. Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes of a study medication, whichever is of longer duration, prior study start.
9. Patient has already been recruited in this trial.
10. Patients who do not understand the nature, the scope and the consequences of the clinical trial.
11. Patient who might be dependent on the sponsor, the study site or the investigator.
12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 Nr. 4 AMG.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02812992
Study Brief:
Protocol Section:
NCT02812992