Pancreatic CancerPhase 2APC-S1NCT01074996
Study of S-1 as Second Line Treatment on Advanced Pancreatic Cancers
A Phase 2 study testing S-1 and S-1 plus Leucovorin in people with Pancreatic Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1 plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable or advanced pancreatic cancers，investigate the correlation between efficacy and the expressions of thymidylate synthase… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- S-1 and S-1 plus Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Jul 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed inoperable or APC.
- Failure of one prior gemcitabine-based regimen was required,chemotherapy used as a radiation sensitizer in the adjuvant or locally advanced setting was not considered as a prior regimen. Patients received last adjuvant gemcitabine-based chemotherapy less than (or equal to) six months can be enrolled into this study.
- Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Age ≥18 years old.
- ECOG performance status 0 or 1.
- Written informed consent and able to comply with the protocol.
Who cannot join
- Local (Stage IA to IIB) pancreatic cancer and locally advanced (stage III) pancreatic cancer. Patients relapsing with metastatic disease, after initial diagnoses with local disease can be enrolled into this study.
- Previous adjuvant radiotherapy for pancreatic cancer, except for patients with progressive lesions outside the radiation port who completed the radiotherapy at least 6 months prior to study entry.
- More than (or equal to) six months since last adjuvant chemotherapy. Adjuvant therapy without gemcitabine based adjuvant therapy is not allowed. Patient must have recovered from all treatment related toxicity prior to enrollment and must have documented evidence of disease progression (metastatic) following prior chemotherapy.
- No previous gemcitabine-based therapy for inoperable or APC.
- Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
- Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
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- History or evidence upon neurological exam of CNS disease (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures.
- Inability to take oral medication, prior surgical procedures affecting absorption or resulting in the requirement for intravenous alimentation or parenteral nutrition with lipids, and/or active peptic ulcer disease
- Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start
- Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
- Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
- Known hypersensitivity to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized , Open-label, Multicenter, Phase II Study to Compare the Efficacy of S-1 and S-1 Plus Leucovorin as Second Line Treatment on Gemcitabine-refractory Patients With Inoperable or Advanced Pancreatic Cancers
A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1 plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable or advanced pancreatic cancers，investigate the correlation between efficacy and the expressions of thymidylate synthase, dihydropyrimidine dehydrogenase and orotate phosphoribosyltransferase
- Conditions
- Pancreatic Cancer
- Being tested
- S-1, S-1 plus Leucovorin
- Keywords
- Pancreatic cancer, S-1, S-1 plus Leucovorin, second-line therapy
- 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-1Drug
40-60mg bid , days 1-14, every 3 weeks
S-1 plus LeucovorinDrug
S-1 40-60mg bid, days 1-14 , every 3 weeks Leucovorin 25mg bid , days 1-14 , every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| S-1, | Active comparator | Subjects will receive S-1 until progression Receives: Drug: S-1 |
| S-1 plus Leucovorin | Experimental | patients will receive S-1 plus Leucovorin until progression Receives: Drug: S-1 plus Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
Assuming a 1.8 months median PFS in the S-1 arm, the study was designed to detect an improvement in PFS to 3.5 months in the S-1 plus Leucovorin arm, or 96% prolongation. The calculated number of PFS events needed to detect this difference with α (two-side) of 0.05 and power of 0.8 was 70. Assuming an average enrollment rate of 2.2 patients per month during planned 3-years study period, a total of eighty patients would be able to provide sufficient number of PFS events for the study at end of the study. However, a total of 90 patients were planned for the study, in consideration of comparison for safety and the overall survival between the two treatment groups.
Measured: up to 3 years
Secondary outcomes (4)
overall survival
Measured: up to 3 years
Tumor response rate
Measured: up to 3 years
Clinical benefit rate
Measured: up to 3 years
safety and tolerance
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2013
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu jianming, M.D., Principal investigator, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074996
- Sponsor's protocol ID
- APC-307PLAH-XJM
- Acronym
- APC-S1
- Status last verified
- Jan 2014
- First submitted
- 23 Feb 2010
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ge F, Xu N, Bai Y, Ba Y, Zhang Y, Li F, Xu H, Jia R, Wang Y, Lin L, Xu J. S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study. Oncologist. 2014 Nov;19(11):1133-4. doi: 10.1634/theoncologist.2014-0223. Epub 2014 Oct 1.
PubMed 25273077
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized , Open-label, Multicenter, Phase II Study to Compare the Efficacy of S-1 and S-1 Plus Leucovorin as Second Line Treatment on Gemcitabine-refractory Patients With Inoperable or Advanced Pancreatic Cancers
- ClinicalTrials.gov ID
- NCT01074996
- Acronym / sponsor ID
- APC-S1 / APC-307PLAH-XJM
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, S-1, S-1 plus Leucovorin, second-line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 24 Feb 2010 (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.
A randomized , open-label, multicenter, phase II study to compare the efficacy of S-1 and S-1 plus Leucovorin as second line treatment on gemcitabine-refractory patients with inoperable or advanced pancreatic cancers，investigate the correlation between efficacy and the expressions of thymidylate synthase, dihydropyrimidine dehydrogenase and orotate phosphoribosyltransferase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1, | Active comparator | Drug: S-1Subjects will receive S-1 until progression |
| S-1 plus Leucovorin | Experimental | Drug: S-1 plus Leucovorinpatients will receive S-1 plus Leucovorin until progression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed inoperable or APC.
- Failure of one prior gemcitabine-based regimen was required,chemotherapy used as a radiation sensitizer in the adjuvant or locally advanced setting was not considered as a prior regimen. Patients received last adjuvant gemcitabine-based chemotherapy less than (or equal to) six months can be enrolled into this study.
- Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Age ≥18 years old.
- ECOG performance status 0 or 1.
Key exclusion criteria (13 listed)
- Local (Stage IA to IIB) pancreatic cancer and locally advanced (stage III) pancreatic cancer. Patients relapsing with metastatic disease, after initial diagnoses with local disease can be enrolled into this study.
- Previous adjuvant radiotherapy for pancreatic cancer, except for patients with progressive lesions outside the radiation port who completed the radiotherapy at least 6 months prior to study entry.
- More than (or equal to) six months since last adjuvant chemotherapy. Adjuvant therapy without gemcitabine based adjuvant therapy is not allowed. Patient must have recovered from all treatment related toxicity prior to enrollment and must have documented evidence of disease progression (metastatic) following prior chemotherapy.
- No previous gemcitabine-based therapy for inoperable or APC.
- Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
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-140-60mg bid , days 1-14, every 3 weeks | Drug | S-1, |
| S-1 plus LeucovorinS-1 40-60mg bid, days 1-14 , every 3 weeks Leucovorin 25mg bid , days 1-14 , every 3 weeks | Drug | S-1 plus Leucovorin |
Primary outcome
Progression Free Survival(PFS)
Time frame: up to 3 years
Assuming a 1.8 months median PFS in the S-1 arm, the study was designed to detect an improvement in PFS to 3.5 months in the S-1 plus Leucovorin arm, or 96% prolongation. The calculated number of PFS events needed to detect this difference with α (two-side) of 0.05 and power of 0.8 was 70. Assuming an average enrollment rate of 2.2 patients per month during planned 3-years study period, a total of eighty patients would be able to provide sufficient number of PFS events for the study at end of the study. However, a total of 90 patients were planned for the study, in consideration of comparison for safety and the overall survival between the two treatment groups.
4 secondary outcomes
overall survival
Time frame: up to 3 years
Tumor response rate
Time frame: up to 3 years
Clinical benefit rate
Time frame: up to 3 years
safety and tolerance
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
- Derived from this study: PubMed 25273077Ge F, Xu N, Bai Y, Ba Y, Zhang Y, Li F, Xu H, Jia R, Wang Y, Lin L, Xu J. S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study. Oncologist. 2014 Nov;19(11):1133-4. doi: 10.1634/theoncologist.2014-0223. Epub 2014 Oct 1.
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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.
Xu jianming, M.D. principal investigator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 and S-1 plus Leucovorin in people with Pancreatic Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
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 6 inclusion and 13 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 16 Jan 2014. 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 China. 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?
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?
Progression Free Survival(PFS) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074996, which also lists 1 linked publication.
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 16 Jan 2014.