Pancreatic CancerNCT00994721
A Phase III Study of Pancreatic Cancer
An observational study of Pancreatic Cancer, run by National Health Research Institutes, Taiwan at 3 sites in Taiwan.
Trial summary
Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 147 participants
- Where
- 3 sitesTaiwan
- Study dates
- Feb 2009to Jan 2016
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic andenocarcinoma. With a significant level of 0.05,107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214(107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.
A.Eligibility Criteria
- Patients with pancreatic cancer after curative intent resection.
- The histology of resected tumor has to be adenocarcinoma.
- Age 20-75 years.
- ECOG performance scale 0-1.
- Patients must have normal organ and marrow function as defined below.
- The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown.
- to sign a written informed consent.
- Registered within 6 weeks after surgery.
- Preoperative abdominal CT or MRI with contrast enhancement.
B.Exclusion Criteria
- Patients with gross residual, macroscopic positive resection margin or distant metastases.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions.
- Patients who had non-curable second primary malignancy.
- Uncontrolled intercurrent illness including.
- Pregnant women.
- receiving immuno-suppressive therapy、anti-coagulants.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Chang-Gung Memorial Hospital
Taipei
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
About this study
Official title: A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection
Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative resection.
Research Objective and Study End Points
Read more
- Primary endpoint： The primary end point is disease free survival.
- Secondary endpoints： The secondary end points are to evaluate the overall survival, local and distant recurrence rate, and impact on quality of life after adjuvant gemcitabine with or without CCRT in curatively resected pancreatic cancer.
Furthermore, the clinical, pathological and molecular prognostic factors in curatively resected pancreatic cancers will be evaluated.
Read the detailed description
Treatment plan and Randomization scheme:：
Patients will be randomized after stratification according to pathology report on section margin, tumor size, lymph node metastasis:
Patients who are randomized to Arm 1 will receive adjuvant chemotherapy started within 4-8 weeks after the surgery, and administered at D1, D8 and D15 every 4 weeks for 6 cycles (6 months). Patients who are allocated to Arm 2 will receive sandwich treatment, which comprised of the same adjuvant chemotherapy within 4-8 weeks after the surgery for 3 cycles (3 months), followed by CCRT (start 4-6 weeks after the last dose of 3rd cycle chemotherapy) and then another 3 cycles of gemcitabine monotherapy.
Statistical Consideration:
We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic adenocarcinoma. With a significant level of 0.05, 107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214 (107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.
Randomization scheme:
Histo-/cyto-logically confirmed macroscopic complete resected pancreatic adenocarcinoma
- The primary end-point is disease free survival.
- The secondary end-points are overall survival; local and distant control rate, and the quality of life.
- The clinical and molecular prognostic factors for overall survival.
- Radiation fields encompass initial main tumor of pancreas only with a safe margin of 1cm. Lymph node regions initially involved with tumor confirmed by excision will be included in the clinical target volume. Elective radiation to uninvolved lymph nodes will not be given.
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic cancer | resected pancreatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point is recurrence-free survival.
Measured: Pancreatic Cancer Disease Committee
Secondary outcomes (1)
The secondary end-points are overall survival; local and distant control rate, and the quality of life.
Measured: Pancreatic Cancer Disease Committee
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2016
- Study completionJan 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Veterans General Hospital., Kaohsiung Medical University
- Responsible party
- Sponsor
- Investigators
- Tsann-Long Hwang, M.D., Study chair, Chang Gung Memorial HospitalYu-Wen Tien Tien, Ph.D., Principal investigator, National Taiwan University HospitalYi-Ming Shyr, M.D., Principal investigator, Taipei Veterans General Hospital, TaiwanPin-Wen Lin, M.D, Principal investigator, National Cheng-Kung University HospitalYu-Lin Lin, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994721
- Sponsor's protocol ID
- T3207
- Status last verified
- Oct 2009
- First submitted
- 26 Mar 2008
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chiu YF, Liu TW, Shan YS, Chen JS, Li CP, Ho CL, Hsieh RK, Hwang TL, Chen LT, Ch'ang HJ; Taiwan Cooperative Oncology Group pancreatic cancer study group. Carbohydrate Antigen 19-9 Response to Initial Adjuvant Chemotherapy Predicts Survival and Failure Pattern of Resected Pancreatic Adenocarcinoma but Not Which Patients Are Suited for Additional Adjuvant Chemoradiation Therapy: From a Prospective Randomized Study. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):74-86. doi: 10.1016/j.ijrobp.2023.02.061. Epub 2023 Apr 11.
PubMed 37055279
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection
- ClinicalTrials.gov ID
- NCT00994721
- Acronym / sponsor ID
- T3207
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Veterans General Hospital., Kaohsiung Medical University
- Study start
- Feb 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Oct 2009 (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.
Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative resection.
Research Objective and Study End Points
- Primary endpoint： The primary end point is disease free survival.
- Secondary endpoints： The secondary end points are to evaluate the overall survival, local and distant recurrence rate, and impact on quality of life after adjuvant gemcitabine with or without CCRT in curatively resected pancreatic cancer.
Furthermore, the clinical, pathological and molecular prognostic factors in curatively resected pancreatic cancers will be evaluated.
Detailed description
Treatment plan and Randomization scheme:：
Patients will be randomized after stratification according to pathology report on section margin, tumor size, lymph node metastasis:
Patients who are randomized to Arm 1 will receive adjuvant chemotherapy started within 4-8 weeks after the surgery, and administered at D1, D8 and D15 every 4 weeks for 6 cycles (6 months). Patients who are allocated to Arm 2 will receive sandwich treatment, which comprised of the same adjuvant chemotherapy within 4-8 weeks after the surgery for 3 cycles (3 months), followed by CCRT (start 4-6 weeks after the last dose of 3rd cycle chemotherapy) and then another 3 cycles of gemcitabine monotherapy.
Statistical Consideration:
We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic adenocarcinoma. With a significant level of 0.05, 107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214 (107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.
Randomization scheme:
Histo-/cyto-logically confirmed macroscopic complete resected pancreatic adenocarcinoma
- The primary end-point is disease free survival.
- The secondary end-points are overall survival; local and distant control rate, and the quality of life.
- The clinical and molecular prognostic factors for overall survival.
- Radiation fields encompass initial main tumor of pancreas only with a safe margin of 1cm. Lymph node regions initially involved with tumor confirmed by excision will be included in the clinical target volume. Elective radiation to uninvolved lymph nodes will not be given.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic cancer | – | –resected pancreatic cancer |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic andenocarcinoma. With a significant level of 0.05,107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214(107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary end-point is recurrence-free survival.
Time frame: Pancreatic Cancer Disease Committee
1 secondary outcome
The secondary end-points are overall survival; local and distant control rate, and the quality of life.
Time frame: Pancreatic Cancer Disease Committee
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 4 May 2016.
- Derived from this study: PubMed 37055279Chiu YF, Liu TW, Shan YS, Chen JS, Li CP, Ho CL, Hsieh RK, Hwang TL, Chen LT, Ch'ang HJ; Taiwan Cooperative Oncology Group pancreatic cancer study group. Carbohydrate Antigen 19-9 Response to Initial Adjuvant Chemotherapy Predicts Survival and Failure Pattern of Resected Pancreatic Adenocarcinoma but Not Which Patients Are Suited for Additional Adjuvant Chemoradiation Therapy: From a Prospective Randomized Study. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):74-86. doi: 10.1016/j.ijrobp.2023.02.061. Epub 2023 Apr 11.
- 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.
Tsann-Long Hwang, M.D. study chair
Chang Gung Memorial Hospital
Yu-Wen Tien Tien, Ph.D. principal investigator
National Taiwan University Hospital
Yi-Ming Shyr, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by National Health Research Institutes, Taiwan at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
The primary end-point is recurrence-free survival. (time frame: Pancreatic Cancer Disease Committee). 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 NCT00994721, 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 4 May 2016.