Locally Advanced Pancreatic CancerPhase 2NCT01063192
A Study of Locally Advanced Pancreatic Cancer
A Phase 2 study testing Gemcitabine and Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL) in people with Locally Advanced Pancreatic Cancer, run by National Health Research Institutes, Taiwan.
Trial summary
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Gemcitabine and Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Sep 2016
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
- Patients must have locally advanced pancreatic cancer (LAPC).
- Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- Patients must have measurable disease.
- Age >20 years.
- ECOG performance scale of 0-2.
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- Patients must have normal organ and marrow function.
- Patients who present with jaundice, temporary or permanent internal / external drainage before enrollment will be allowed.
- The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with distant metastases are not eligible.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
- Patients who have above grade II peripheral neuropathy.
- Patients who had non-curable second primary malignancy.
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- Uncontrolled intercurrent illness including.
- Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects.
- Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study.
About this study
Official title: A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.
The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.
Read the detailed description
Patients should be randomized to two study arms stratified by resectability status (borderline resectable and unresectable) after enrollment. Eligible patients will be randomly assigned on a 1:1 basis to either of two study groups, using a central randomization procedure with stratification according to NCCN criteria of resectability.
After randomization, induction chemotherapy (ICT) will be administered for 3 cycles ( 3 months). Patients who have radiological evidence of distant dissemination will be shifted to salvage chemotherapy. Patients who have responsive, stable disease as well as those with localized progressive disease after ICT will receive concurrent chemoradiotherapy (CCRT) 3-4 weeks after the last dose of ICT. Surgical evaluation will be performed 4-6 weeks after the completion of CCRT. Patients who have respectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy for 3 cycles ( 3 months) will be given for those who are considered to have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy till disease progression or unacceptable toxicity.
For Arm 1, ICT with gemcitabine ( fixed rate of 10mg/m2/min, 1000mg/m2 on day 1,8,15 every 28 days/cycle) will be administered on a 3-week-on-one-week-off weekly basis. For Arm 2, ICT with GOFL ( 800mg/m2 gemcitabine at a fixed rate of 10mg/m2/min followed by a 2-hour oxaliplatin 85mg/m2 and then a 48-hour 3000mg/m2 5-FU and 150 mg/m2 leucovorin on day 1 and 15 every 28 days/cycle) will be given biweekly.
After three 3 cycles of ICT, patients without distant metastasis will be given CCRT with gemcitabine 400mg/m2 2 hrs before RT on day1,8,15,22,29,36. Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.
If complete surgical resection is feasible, optimal surgery will be performed 4-6 weeks after CCRT. If complete surgical resection is impossible, biopsy with or without bypass surgery may be performed. Patients who have curative surgical resection will receive additional 6 cycles ( 6 months) of adjuvant chemotherapy ( Arm1, gemcitabine alone; Arm 2, GOFL) within 4 weeks after surgery and then followed up until tumor progression. Patients who are not feasible for curative resection, will receive continued chemotherapy (Arm1, gemcitabine alone; Arm2, GOFL) 3-4 weeks after CCRT complete. The regimen will continue till disease progression.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Gemcitabine, Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)
- Keywords
- Locally Advanced Pancreatic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Arm 1: Gemcitabine alone on D1,8,15 every 28 days for 3 cycles
Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)Drug
Arm 2: GOFL on D1, 15 every 28 days for 3 cycles(Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr)
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Arm 1: Gemcitabine alone Receives: Drug: Gemcitabine |
| GOFL | Active comparator | Arm 2: GOFL (Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr) Receives: Drug: Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.
Measured: 6 months
Secondary outcomes (1)
The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionSep 2013 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Investigators
- Pin-Wen Lin, M.D, Study chair, National Cheng-Kung University HospitalYen-Shen Shen, M.D., Principal investigator, National Cheng-Kung University HospitalChiun Hsu, Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063192
- Sponsor's protocol ID
- T2209
- Status last verified
- Feb 2010
- First submitted
- 4 Nov 2009
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01063192
- Acronym / sponsor ID
- T2209
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- Locally Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, National Cheng-Kung University Hospital
- Study start
- Nov 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 5 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.
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.
The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.
Detailed description
Patients should be randomized to two study arms stratified by resectability status (borderline resectable and unresectable) after enrollment. Eligible patients will be randomly assigned on a 1:1 basis to either of two study groups, using a central randomization procedure with stratification according to NCCN criteria of resectability.
After randomization, induction chemotherapy (ICT) will be administered for 3 cycles ( 3 months). Patients who have radiological evidence of distant dissemination will be shifted to salvage chemotherapy. Patients who have responsive, stable disease as well as those with localized progressive disease after ICT will receive concurrent chemoradiotherapy (CCRT) 3-4 weeks after the last dose of ICT. Surgical evaluation will be performed 4-6 weeks after the completion of CCRT. Patients who have respectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy for 3 cycles ( 3 months) will be given for those who are considered to have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy till disease progression or unacceptable toxicity.
For Arm 1, ICT with gemcitabine ( fixed rate of 10mg/m2/min, 1000mg/m2 on day 1,8,15 every 28 days/cycle) will be administered on a 3-week-on-one-week-off weekly basis. For Arm 2, ICT with GOFL ( 800mg/m2 gemcitabine at a fixed rate of 10mg/m2/min followed by a 2-hour oxaliplatin 85mg/m2 and then a 48-hour 3000mg/m2 5-FU and 150 mg/m2 leucovorin on day 1 and 15 every 28 days/cycle) will be given biweekly.
After three 3 cycles of ICT, patients without distant metastasis will be given CCRT with gemcitabine 400mg/m2 2 hrs before RT on day1,8,15,22,29,36. Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.
If complete surgical resection is feasible, optimal surgery will be performed 4-6 weeks after CCRT. If complete surgical resection is impossible, biopsy with or without bypass surgery may be performed. Patients who have curative surgical resection will receive additional 6 cycles ( 6 months) of adjuvant chemotherapy ( Arm1, gemcitabine alone; Arm 2, GOFL) within 4 weeks after surgery and then followed up until tumor progression. Patients who are not feasible for curative resection, will receive continued chemotherapy (Arm1, gemcitabine alone; Arm2, GOFL) 3-4 weeks after CCRT complete. The regimen will continue till disease progression.
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: GemcitabineArm 1: Gemcitabine alone |
| GOFL | Active comparator | Drug: Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)Arm 2: GOFL (Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
- Patients must have locally advanced pancreatic cancer (LAPC).
- Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- Patients must have measurable disease.
- Age >20 years.
Key exclusion criteria (9 listed)
- Patients with distant metastases are not eligible.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
- Patients who have above grade II peripheral neuropathy.
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 |
|---|---|---|
| GemcitabineArm 1: Gemcitabine alone on D1,8,15 every 28 days for 3 cycles | Drug | Gemcitabine |
| Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)Arm 2: GOFL on D1, 15 every 28 days for 3 cycles(Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr) | Drug | GOFL |
Primary outcome
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.
Time frame: 6 months
1 secondary outcome
The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy .
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
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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.
Pin-Wen Lin, M.D study chair
National Cheng-Kung University Hospital
Yen-Shen Shen, M.D. principal investigator
National Cheng-Kung University Hospital
Chiun Hsu, Ph.D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL) in people with Locally Advanced Pancreatic Cancer, run by National Health Research Institutes, Taiwan.
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 9 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 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. (time frame: 6 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 5 Feb 2010.