Pancreatic NeoplasmsPhase 2NCT02754180
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
A Phase 2 study testing Gemcitabine and TS-1 with radiation in people with Pancreatic Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Gemcitabine and TS-1 with radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
- Subject should start treatment no later than 10 weeks postsurgery.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Acceptable hematology parameters:
- Absolute neutrophil count ≥1500 cell/mm3
- Platelet count ≥100,000/mm3
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- Hemoglobin (Hgb) ≥8.0 g/dL
- Acceptable blood chemistry levels:
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
- Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
- Serum creatinine within upper limits of normal.
- Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
- No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
- Signed informed consent.
Who cannot join
- R2 resection or presence of metastatic disease.
- Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
- Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
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- Transmural myocardial infarction within the 6 months of study registration
- Uncontrolled hypertension, diabetes or arrhythmia.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
- Not able to take medicine orally.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, 100730
Yuejuan Cheng, M.D., 861069158315, cnchengyuejuan@yahoo.com
Bai Chunmei, MD
About this study
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Read the detailed description
Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Gemcitabine, TS-1 with radiation
- Keywords
- adjuvant, pancreatic cancer, R1 resection, positive lymph nodes
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called chemotherapy
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
TS-1 with radiationRadiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Active comparator | gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Receives: Drug: Gemcitabine |
| chemotherapy with chemoradiation | Experimental | gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation. Receives: Drug: Gemcitabine; Radiation: TS-1 with radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (2)
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: from randomization to 1 month after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YueJuan Cheng, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754180
- Sponsor's protocol ID
- ZS-1015
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
- ClinicalTrials.gov ID
- NCT02754180
- Acronym / sponsor ID
- ZS-1015
- Conditions
- Pancreatic Neoplasms
- Keywords
- adjuvant, pancreatic cancer, R1 resection, positive lymph nodes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 28 Apr 2016 (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.
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Detailed description
Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Drug: Gemcitabinegemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. |
| chemotherapy with chemoradiation | Experimental | Drug: Gemcitabine, Radiation: TS-1 with radiationgemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
- Subject should start treatment no later than 10 weeks postsurgery.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Acceptable hematology parameters:
- Acceptable blood chemistry levels:
Key exclusion criteria (10 listed)
- R2 resection or presence of metastatic disease.
- Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
- Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- Severe, active co-morbidity, defined as follows:
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 |
|---|---|---|
| GemcitabineAlso: chemotherapygemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles | Drug | chemotherapy, chemotherapy with chemoradiation |
| TS-1 with radiationgemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation. | Radiation | chemotherapy with chemoradiation |
Primary outcome
Disease free survival
Time frame: From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months
2 secondary outcomes
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: from randomization to 1 month after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- 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.
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 Gemcitabine and TS-1 with radiation in people with Pancreatic Neoplasms, run by Peking Union Medical College Hospital 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 14 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: status not confirmed, as of the sponsor's last update on 28 Apr 2016. 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?
Contact Bai Chunmei, MD (861069158773, baichunmei1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 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 28 Apr 2016.