Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

Metastatic Pancreas Cancer Clinical Trial

— TIMEPAN  

Official title:

TIming of Start of systemIc Treatment for Asymptomatic MEtastasized PANcreatic Cancer (TIMEPAN): a Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897854
• Other study ID #: NL722253.018.19
• Status: Recruiting
• Phase: Phase 3
• Start date: April 22, 2021
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: J.W. Wilmink, Dr.
• Phone: +31 20 5628065
• Email: j.w.wilmink[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Since patients with metastatic pancreatic cancer have a limited life expectancy, it is important to determine the timing of when to start chemotherapy in order to optimize the benefits of chemotherapy relative to the side effects. Therefore, two treatment strategies can be considered: chemotherapy started immediately at diagnosis, or delayed until disease-related symptoms occur.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
• Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
• Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
• Eastern Cooperative Oncology Group Performance Status of 0-1
• Life expectancy = 3 months.
• Age = 18 years.
• A negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential.
• Screening clinical laboratory values as follows:

1. Absolute neutrophil count > 1.5 x 109 /L

2. Total bilirubin = 1.5 times upper limit of normal (ULN).

3. Aspartate aminotransferase and alanine aminotransferase = 2.5 times ULN, (if liver metastases are present, then = 5 times ULN is allowed).

4. Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2

5. Prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%).

6. Platelet count > 100,000 x 109 /L

• No symptoms related to advanced disease, specified as:

1. no pain requiring regular narcotic analgesics;

2. no weight loss over 5 kg (unless related to surgery or other illness);

3. no persistent nausea requiring medication;

4. no obstructive bowel symptoms;

5. no persistent fever related to metastatic cancer;

6. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer.

• No prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease)

Exclusion Criteria:

• Known central nervous system involvement or brain metastases.
• New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
• 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.
• Inability to comply with study and follow-up procedures as judged by the Investigator.
• Women currently pregnant or breastfeeding.

Related Conditions & MeSH terms

• Metastatic Pancreas Cancer
• Neoplasm Metastasis
• Pancreatic Neoplasms

Intervention

Drug:
• Folfirinox
In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of CA 19.9	Exploratory endpoint	From date of randomization until the date of death, assessed up to 12 months
Primary	Quality adjusted overall survival	Measured in "utility-per-month", using the survival in months and the monthly reported quality of life by the EQ-5D-5L questionaire.	From date of randomization until the date of death, assessed up to 12 months
Secondary	Time to disease progression	Restricted mean progression free survival (RM-PFS): are under the Kaplan-Meier PFS curve between randomization and follow-up of the study (estimated 12 months)	12 months
Secondary	Quality adjusted progression free survival (PFS)		From date of randomization until the date of death, assessed up to 12 months
Secondary	Duration of time without symptoms of disease progression or toxicities (TWiST)		From date of randomization until the date of death, assessed up to 12 months
Secondary	Overall survival	(In months)	From date of randomization until the date of death, assessed up to 12 months
Secondary	Number of patients with adverse events	According to NCI CTC version 5.0	From date of randomization until the date of death, assessed up to 12 months