TIming of start of systemIc treatment for asymptomatic MEtastasized PANcreatic cancer (TIMEPAN): a prospective multicenter patient preference cohort.
- Conditions
- Pancreatic cancer10017990
- Registration Number
- NL-OMON52527
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 184
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.
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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Quality Adjusted Survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to disease progression after randomization.<br /><br>Adverse events according to NCI CTC version 5.0.</p><br>