Metastatic Pancreatic CancerPhase 1SR-GSNCT01946646
Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer
A Phase 1 study testing S-1-CCRT in people with Metastatic Pancreatic Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- S-1-CCRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Jan 2017
- Phase
- Phase 1
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
- no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
- presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
- age between 20 and 79 years at registration
- ECOG PS of 0 or 1
- adequate major organ functions
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- ability to take the oral study medication (TS-1)
- no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
- voluntarily signed the written informed consent form
Who cannot join
- pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
- presence of diarrhea ≥ CTCAE v.4.03 grade 2
- concomitant active infection or significant co-morbid medical conditions
- moderate or severe ascites or pleural effusion that requires drainage
- central nervous system metastasis
- prior or concurrent malignancies within the last 3 years
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- concomitant treatment with flucytosine, phenytoin or warfarin
- pregnant women or nursing mothers, or positive pregnancy test
- severe mental disorder
- judged ineligible by physician for participation in the study due to safety concern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)
The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- S-1-CCRT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1-CCRTDrug
| Study group | Role | What they receive |
|---|---|---|
| S-1-CCRT | Experimental | There are five dose levels and one arm only. Level 1: S-1, 25 mg/m2, bid, Day 1-14; RT 25 Gy/10 fx, Day 1-5, 8-12 Level 2: S-1, 25 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 3: S-1, 30 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 4: S-1, 30 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 Level 5: S-1, 35 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 All dose levels are followed by Gemcitabine/S-1 (G 1000 mg/m2, iv, D1 and 15 plus S-1 60/80/100 mg/day based on BSA, po, D1-7, D15-21, q4w) after the CCRT Receives: Drug: S-1-CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT:
- grade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more
- grade 3 leucopenia and/or neutropenia with infection
- grade 4 leucopenia and/or neutropenia lasting 3 days or more
- grade 4 leucopenia and/or neutropenia requiring G-CSF
- platelet < 25,000/mm3
- , grade 3 thrombocytopenia requiring transfusion
- hemoglobin < 8.0 g/dL
- serum AST/ALT ≥ 10 times ULN h. total bilirubin ≥ 3 times ULN i. creatinine >3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD.
Measured: 6 weeks
maximum-tolerated dose
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TTY Biopharm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946646
- Sponsor's protocol ID
- 201211048MPC
- Acronym
- SR-GS
- Status last verified
- Jan 2017
- First submitted
- 11 Sep 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)
- ClinicalTrials.gov ID
- NCT01946646
- Acronym / sponsor ID
- SR-GS / 201211048MPC
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- TTY Biopharm
- Study start
- Oct 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Sep 2013 (estimated)
- 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.
The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in 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 |
|---|---|---|
| S-1-CCRT | Experimental | Drug: S-1-CCRTThere are five dose levels and one arm only. Level 1: S-1, 25 mg/m2, bid, Day 1-14; RT 25 Gy/10 fx, Day 1-5, 8-12 Level 2: S-1, 25 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 3: S-1, 30 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 4: S-1, 30 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 Level 5: S-1, 35 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 All dose levels are followed by Gemcitabine/S-1 (G 1000 mg/m2, iv, D1 and 15 plus S-1 60/80/100 mg/day based on BSA, po, D1-7, D15-21, q4w) after the CCRT |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
- no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
- presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
- age between 20 and 79 years at registration
- ECOG PS of 0 or 1
Key exclusion criteria (10 listed)
- pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
- presence of diarrhea ≥ CTCAE v.4.03 grade 2
- concomitant active infection or significant co-morbid medical conditions
- moderate or severe ascites or pleural effusion that requires drainage
- central nervous system metastasis
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 |
|---|---|---|
| S-1-CCRT | Drug | S-1-CCRT |
Primary outcome
maximum tolerated dose
Time frame: 6 weeks
Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT: 1. grade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more 2. grade 3 leucopenia and/or neutropenia with infection 3. grade 4 leucopenia and/or neutropenia lasting 3 days or more 4. grade 4 leucopenia and/or neutropenia requiring G-CSF 5. platelet < 25,000/mm3 6. , grade 3 thrombocytopenia requiring transfusion 7. hemoglobin < 8.0 g/dL g. serum AST/ALT ≥ 10 times ULN h. total bilirubin ≥ 3 times ULN i. creatinine >3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD.
maximum-tolerated dose
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-1-CCRT in people with Metastatic Pancreatic Cancer, run by National Taiwan University Hospital at 1 site 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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 Jan 2017. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
maximum tolerated dose (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 18 Jan 2017.