Metastatic Pancreas CancerPhase 3TIMEPANNCT04897854
Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer
A Phase 3 study testing Folfirinox in people with Metastatic Pancreas Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreas Cancer
- What is being tested?
- Folfirinox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Apr 2021to 22 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- Absolute neutrophil count > 1.5 x 109 /L
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN).
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed).
- Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2
- 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%).
- Platelet count > 100,000 x 109 /L
- No symptoms related to advanced disease, specified as:
- no pain requiring regular narcotic analgesics;
- no weight loss over 5 kg (unless related to surgery or other illness);
- no persistent nausea requiring medication;
- no obstructive bowel symptoms;
- no persistent fever related to metastatic cancer;
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
S. Augustinus contact
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105AZ
J.W. Wilmink, Dr., +31 20 5628065, j.w.wilmink@amsterdamumc.nl
About this study
Official title: TIming of Start of systemIc Treatment for Asymptomatic MEtastasized PANcreatic Cancer (TIMEPAN): a Randomized Controlled Multicenter Trial
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.
- Conditions
- Metastatic Pancreas Cancer
- Being tested
- Folfirinox
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolfirinoxDrug
In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Active comparator | The treatment schedule will be direct (start within 3 weeks of bate of diagnosis) FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol. Receives: Drug: Folfirinox |
| Delayed treatment | Active comparator | The treatment schedule will be delayed treatment (based on symptoms) with FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol.
Chemotherapy will start as soon as one of the following criteria is met:
* Decline in performance status to ECOG < 1 or Karnofsky < 80%
* Weight loss more than 5% of the total body weight from the time of study entry
* Persistent nausea requiring medication
* Pain requiring regular narcotic analgesics
* Development of clinically significant third-space fluid collections
* Liver function deterioration in the presence of progressive liver metastases Receives: Drug: Folfirinox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until the date of death, assessed up to 12 months
Secondary outcomes (5)
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)
Measured: 12 months
Quality adjusted progression free survival (PFS)
Measured: From date of randomization until the date of death, assessed up to 12 months
Duration of time without symptoms of disease progression or toxicities (TWiST)
Measured: From date of randomization until the date of death, assessed up to 12 months
Overall survival
(In months)
Measured: From date of randomization until the date of death, assessed up to 12 months
Number of patients with adverse events
According to NCI CTC version 5.0
Measured: From date of randomization until the date of death, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start22 Apr 2021
- Primary completion22 Apr 2024 (estimated)
- Study completion22 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.W. Wilmink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897854
- Sponsor's protocol ID
- NL722253.018.19
- Acronym
- TIMEPAN
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIming of Start of systemIc Treatment for Asymptomatic MEtastasized PANcreatic Cancer (TIMEPAN): a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT04897854
- Acronym / sponsor ID
- TIMEPAN / NL722253.018.19
- Conditions
- Metastatic Pancreas Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 22 Apr 2024 (estimated)
- Study completion
- 22 Apr 2024 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Active comparator | Drug: FolfirinoxThe treatment schedule will be direct (start within 3 weeks of bate of diagnosis) FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol. |
| Delayed treatment | Active comparator | Drug: FolfirinoxThe treatment schedule will be delayed treatment (based on symptoms) with FOLFIRINOX or nab paclitaxel in combination with gemcitabine per investigator's choice. Dosage and frequency of administration will be according to local protocol. Chemotherapy will start as soon as one of the following criteria is met: * Decline in performance status to ECOG < 1 or Karnofsky < 80% * Weight loss more than 5% of the total body weight from the time of study entry * Persistent nausea requiring medication * Pain requiring regular narcotic analgesics * Development of clinically significant third-space fluid collections * Liver function deterioration in the presence of progressive liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FolfirinoxIn both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice | Drug | Delayed treatment, Immediate treatment |
Primary outcome
Quality adjusted overall survival
Time frame: From date of randomization until the date of death, assessed up to 12 months
Measured in "utility-per-month", using the survival in months and the monthly reported quality of life by the EQ-5D-5L questionaire.
5 secondary outcomes
Time to disease progression
Time frame: 12 months
Quality adjusted progression free survival (PFS)
Time frame: From date of randomization until the date of death, assessed up to 12 months
Duration of time without symptoms of disease progression or toxicities (TWiST)
Time frame: From date of randomization until the date of death, assessed up to 12 months
Overall survival
Time frame: From date of randomization until the date of death, assessed up to 12 months
Number of patients with adverse events
Time frame: From date of randomization until the date of death, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Augustinus contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folfirinox in people with Metastatic Pancreas Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J.W. Wilmink, Dr. (+31 20 5628065, j.w.wilmink@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality adjusted overall survival (time frame: From date of randomization until the date of death, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.