TIming of start of systemIc treatment for asymptomatic MEtastasized PANcreatic cancer

Phase 1

• Conditions: Metastasized pancreatic cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004582-40-NL
• Lead Sponsor: Amsterdam UMC-Location AMC-dept. Internal Medicin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-03
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
2. Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
3. Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
4. Eastern Cooperative Oncology Group Performance Status of 0-1
5. Life expectancy = 3 months.
6. Age = 18 years.
7. No symptoms related to advanced disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147

Exclusion Criteria

1. Known central nervous system involvement or brain metastases.
2. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
3. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
4. Inability to comply with study and follow-up procedures as judged by the Investigator.
5. Women currently pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of immediate versus delayed start of chemotherapy on quality adjusted survival in patients with metastatic pancreatic cancer. ;Secondary Objective: To determine time to disease progression after randomization.<br>To determine the adverse events according to NCI CTC version 5.0.<br>Exploratory objective: to determine change in CA 19.9<br>;Primary end point(s): Quality Adjusted Survival;Timepoint(s) of evaluation of this end point: Quality of Life will be evaluated every 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to disease progression after randomization<br>Adverse events according to NCI CTC version 5.0<br>Change in CA 19.9;Timepoint(s) of evaluation of this end point: End of trial