Pancreatic AdenocarcinomaPhase 2NCT03559348
Locally Advanced or Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing chemotherapy: TS-1, Leucovorin and Gemcitabine in people with Pancreatic Adenocarcinoma, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
Multiple centers, uncontrolled, open-label, non-randomized single-arm study Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- chemotherapy: TS-1, Leucovorin and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesTaiwan
- Study dates
- 3 Apr 2018to 20 Apr 2020
- Phase
- Phase 2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
- Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
- Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
- Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- Baseline ECOG performance status is 2.
- Patients have life expectancy of at least 12 weeks.
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- Patients have age 70 years.
- Patients have adequate organ function.
- Patients with biliary obstruction which is adequate drained before enrollment are eligible.
- Patients agree to have an indwelling venous catheter implanted.
- Women or men of reproductive potential should agree to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign written informed consents.
Who cannot join
- Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- Patients with metastatic lesion in central nervous system.
- Patients with active infection.
- Patients with active cardiopulmonary disease or history of ischemic heart disease.
- Patients who have peripheral neuropathy > grade I of any etiology.
- Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
- Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
China Medical University Hospital
Taichung
Chang-Gung Memorial Hospital
Taipei
About this study
Official title: Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Multiple centers, uncontrolled, open-label, non-randomized single-arm study
Read the detailed description
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)
Secondary objectives:
Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- chemotherapy: TS-1, Leucovorin and Gemcitabine
- Keywords
- in Elderly Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy: TS-1, Leucovorin and GemcitabineDrug
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.
| Study group | Role | What they receive |
|---|---|---|
| Biweekly TS-1, Leucovorin and Gemcitabine (GSL) | Experimental | Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle Receives: Drug: chemotherapy: TS-1, Leucovorin and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The progression-free survival time for elderly patients with advanced pancreatic cancer
Measured: up to 5.0 months
Secondary outcomes (1)
Overall tumor response rate
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start3 Apr 2018
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, China Medical University Hospital, Kaohsiung Medical University, Chang Gung Memorial Hospital, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559348
- Sponsor's protocol ID
- T1217
- Status last verified
- May 2018
- First submitted
- 18 Apr 2018
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03559348
- Acronym / sponsor ID
- T1217
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- in Elderly Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, China Medical University Hospital, Kaohsiung Medical University, Chang Gung Memorial Hospital, National Cheng-Kung University Hospital
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 18 Jun 2018 (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.
Multiple centers, uncontrolled, open-label, non-randomized single-arm study
Detailed description
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)
Secondary objectives:
Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biweekly TS-1, Leucovorin and Gemcitabine (GSL) | Experimental | Drug: chemotherapy: TS-1, Leucovorin and GemcitabineGemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
- Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
- Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
- Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- Baseline ECOG performance status is 2.
Key exclusion criteria (7 listed)
- Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- Patients with metastatic lesion in central nervous system.
- Patients with active infection.
- Patients with active cardiopulmonary disease or history of ischemic heart disease.
- Patients who have peripheral neuropathy > grade I of any etiology.
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 |
|---|---|---|
| chemotherapy: TS-1, Leucovorin and GemcitabineGemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle. | Drug | Biweekly TS-1, Leucovorin and Gemcitabine (GSL) |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 5.0 months
The progression-free survival time for elderly patients with advanced pancreatic cancer
1 secondary outcome
Overall tumor response rate
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy: TS-1, Leucovorin and Gemcitabine in people with Pancreatic Adenocarcinoma, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
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 12 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 5.0 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 29 Jul 2022.