Pancreatic CancerPhase 2NCT02131493
S-1 and and Gemcitabine vs Gemcitabine Alone as Adjuvant Chemotherapy for Patients With Resected Pancreatic Cancer
A Phase 2 study testing S-1, Gemcitabine in people with Pancreatic Cancer, run by Zhejiang University at 1 site in China.
Trial summary
This study is a randomized, open-label, controlled study that will compare the efficacy of S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients with surgically resected pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- S-1, Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
- Pancreatic cancer surgical staging: T 1-3, N0-1, M0.
- Subject should be able to start treatment no later than 12 weeks postsurgery.
- ≥18 years of age at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Acceptable hematology parameters:
- Absolute neutrophil count ≥1500 cell/mm3
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- Platelet count ≥100,000/mm3
- Hemoglobin (Hgb) ≥9 g/dL 7. Acceptable blood chemistry levels:
- Aspartate aminotransferase (AST)/ Serum glutamic oxaloacetic transaminase (SGOT) and Alanine transaminase (ALT)/ Serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
- Total bilirubin ≤ Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead 8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization 9. Acceptable coagulation studies as demonstrated by Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within normal limits (±15%)
Who cannot join
- Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
- Presence of or history of metastatic pancreatic adenocarcinoma
- .Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
- 1).History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 2).History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 3).History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
Official title: A Open-label, Randomized Study of S-1 and and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer
This study is a randomized, open-label, controlled study that will compare the efficacy of S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients with surgically resected pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- S-1, Gemcitabine
- 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, GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Gemcitabine：1000mg/m2，iv 30min，d1, d8,d15 q4w, 6 cycles Receives: Drug: S-1, Gemcitabine |
| S-1+ Gemcitabine | Experimental | S-1：40~60mg bid，d1~14; (S-1 dosage：BSA <1.25m2，40mg bid，1.25m2≤BSA≤1.5m2，50mg bid，BSA>1.5m2， 60mg bid) Gemcitabine：1000mg/m2，iv 30min，d1, d8 q3w, 8 cycles Receives: Drug: S-1, Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease free survival
Measured: 3 years
Secondary outcomes (1)
OS
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia fang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131493
- Sponsor's protocol ID
- ZYYYMedOncoPAC01
- Status last verified
- Feb 2022
- First submitted
- 3 May 2014
- Last updated
- 2 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Randomized Study of S-1 and and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02131493
- Acronym / sponsor ID
- ZYYYMedOncoPAC01
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 6 May 2014 (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.
This study is a randomized, open-label, controlled study that will compare the efficacy of S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients with surgically resected pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: S-1, GemcitabineGemcitabine：1000mg/m2，iv 30min，d1, d8,d15 q4w, 6 cycles |
| S-1+ Gemcitabine | Experimental | Drug: S-1, GemcitabineS-1：40~60mg bid，d1~14; (S-1 dosage：BSA <1.25m2，40mg bid，1.25m2≤BSA≤1.5m2，50mg bid，BSA>1.5m2， 60mg bid) Gemcitabine：1000mg/m2，iv 30min，d1, d8 q3w, 8 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
- Pancreatic cancer surgical staging: T 1-3, N0-1, M0.
- Subject should be able to start treatment no later than 12 weeks postsurgery.
- ≥18 years of age at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Acceptable hematology parameters:
Key exclusion criteria (8 listed)
- Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
- Presence of or history of metastatic pancreatic adenocarcinoma
- .Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
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, Gemcitabine | Drug | Gemcitabine, S-1+ Gemcitabine |
Primary outcome
DFS
Time frame: 3 years
Disease free survival
1 secondary outcome
OS
Time frame: 5 years
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 2 Mar 2022.
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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.
Weijia fang, MD principal investigator
First Affiliated Hospital of Zhejiang University
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, Gemcitabine in people with Pancreatic Cancer, run by Zhejiang University 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 12 inclusion and 8 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 2 Mar 2022. 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?
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?
DFS (time frame: 3 years). 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 2 Mar 2022.