Pancreatic CancerPhase 2/3NCT01458717
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
A Phase 2/3 study testing Neoadjuvant chemoradiation and Upfront surgery in people with Pancreatic Cancer, run by Seoul National University Hospital at 5 sites in South Korea.
Trial summary
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. 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?
- Neoadjuvant chemoradiation and Upfront surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Nov 2011to Jan 2018
- Phase
- Phase 2/3
- 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
- >18 years old or <75 years old
- ECOG 0-2
- biopsy proven adenocarcinoma of the pancreas
- no history of previous chemotherapy
- borderline resectable pancreas cancer
- no distant metastasis
Show all 10Show fewer
- WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
- Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
- Creatinine no greater than 1.5 times upper limit of normal
- informed consent
Who cannot join
- history of previous chemotherapy
- history of radiation at >25% area of bone marrow
- stage unspecified, with distant metastasis, recurrent pancreas cancer
- history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
- pregnant, breast-feeding patient
- uncontrolled or active infection
- uncontrolled cardiopulmonary disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Center for Liver Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Seoul National University Bundang Hospital
Seongnam, 463-707
Seoul National University Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Gangnam Severance Hospital
Seoul
About this study
Official title: Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
Read the detailed description
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.
This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.
- Conditions
- Pancreatic Cancer
- Being tested
- Neoadjuvant chemoradiation, Upfront surgery
- Keywords
- pancreas, cancer, borderline resectable, locally advanced, resectability, chemotherapy, radiation, chemoradiation, neoadjuvant, survival, prognosis, recurrence, response rate
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoradiationDrug
- Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
- 4 weeks rest, re-evaluation for resectability
- operation
- start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
Upfront surgeryProcedure or surgery
- Operation at time of diagnosis
- Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
- start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant | Experimental | Neoadjuvant - operation - maintenance chemotherapy Receives: Drug: Neoadjuvant chemoradiation |
| Upfront surgery | Active comparator | Operation - adjuvant chemoradiation - maintenance chemotherapy Receives: Procedure: Upfront surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival rate
2-year actual survival outcome
Measured: 2-year actual survival outcome
Secondary outcomes (7)
Median survival
calculated from overall survival with Kaplan-Meier method
Measured: after at least of 2-years follow up of all participants
1-year survival rate
1-year actual survival rate
Measured: after at least of 1-year follow up of all participants
R0 resection rate
according to pathology report after operation
Measured: within 3 weeks after operation
curative resection rate
according to pathology report after operation
Measured: within 3 weeks after operation
local recurrence
any point during the follow-up period
Measured: within at least 2-years follow up
response rate after neoadjuvant chemoradiation
comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation
Measured: within 6 weeks after completion of neoadjuvant chemoradiation
efficacy of imaging study after neoadjuvant chemoradiation
comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation
Measured: within 3 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2018
- Study completionJan 2018
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 Seoul National 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
- Investigators
- Jin-Young Jang, M.D., Ph.D., Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458717
- Sponsor's protocol ID
- BorderlinePancreas
- Status last verified
- Apr 2018
- First submitted
- 19 Oct 2011
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01458717
- Acronym / sponsor ID
- BorderlinePancreas
- Conditions
- Pancreatic Cancer
- Keywords
- pancreas, cancer, borderline resectable, locally advanced, resectability, chemotherapy, radiation, chemoradiation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Oct 2011 (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.
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
Detailed description
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.
This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant | Experimental | Drug: Neoadjuvant chemoradiationNeoadjuvant - operation - maintenance chemotherapy |
| Upfront surgery | Active comparator | Procedure: Upfront surgeryOperation - adjuvant chemoradiation - maintenance chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >18 years old or <75 years old
- ECOG 0-2
- biopsy proven adenocarcinoma of the pancreas
- no history of previous chemotherapy
- borderline resectable pancreas cancer
Key exclusion criteria (7 listed)
- history of previous chemotherapy
- history of radiation at >25% area of bone marrow
- stage unspecified, with distant metastasis, recurrent pancreas cancer
- history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
- pregnant, breast-feeding patient
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 |
|---|---|---|
| Neoadjuvant chemoradiation* Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * 4 weeks rest, re-evaluation for resectability * operation * start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle | Drug | Neoadjuvant |
| Upfront surgery* Operation at time of diagnosis * Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle | Procedure or surgery | Upfront surgery |
Primary outcome
2-year survival rate
Time frame: 2-year actual survival outcome
2-year actual survival outcome
7 secondary outcomes
Median survival
Time frame: after at least of 2-years follow up of all participants
1-year survival rate
Time frame: after at least of 1-year follow up of all participants
R0 resection rate
Time frame: within 3 weeks after operation
curative resection rate
Time frame: within 3 weeks after operation
local recurrence
Time frame: within at least 2-years follow up
response rate after neoadjuvant chemoradiation
Time frame: within 6 weeks after completion of neoadjuvant chemoradiation
efficacy of imaging study after neoadjuvant chemoradiation
Time frame: within 3 weeks after operation
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 May 2018.
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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.
Jin-Young Jang, M.D., Ph.D. principal investigator
Seoul National University College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neoadjuvant chemoradiation and Upfront surgery in people with Pancreatic Cancer, run by Seoul National University Hospital at 5 sites in South Korea.
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 10 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
2-year survival rate (time frame: 2-year actual survival outcome). 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 May 2018.