Resectable Pancreatic CancerPhase 2NCT02243007
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
A Phase 2 study testing FOLFIRINOX, Gemcitabine/nab-Paclitaxel and Radiation therapy in people with Resectable Pancreatic Cancer and Pancreatic Ductal Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Cancer, Pancreatic Ductal Carcinoma
- What is being tested?
- FOLFIRINOX, Gemcitabine/nab-Paclitaxel and Radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to study entry.
- No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross peritoneal or distant metastases by laparoscopy.
- Patients must be 18 years old or older. There will be no upper age restriction.
- ECOG Performance Status of 0 or 1 are eligible.
- Life expectancy of greater than 3 months.
- Lab Values:
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- ANC ≥ 1500 cells/mm3
- Platelet count at least 100,000 cells/mm3.
- AST and ALT ≤2.5 x upper limit of normal
- Total Bilirubin ≤ 5 x upper limit of normal if patient is s/p biliary stenting AND decreasing at least two time points after stenting.
- Total Bilirubin ≤ 1.5 x upper limit of normal if no biliary stenting was done
- Serum Creatinine ≤1.5mg/dl OR
- Creatinine Clearance greater than or equal to 30ml/min (as estimated by Cockroft Gault Equation) (140 - age [yrs]) (body wt [kg])
- Creatinine clearance for males = ------------ (72) (serum creatinine [mg/dL])
- Creatinine clearance for females = 0.85 x male value
- The effects of radiation on the developing human fetus are known to be teratogenic. 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 treatment plus 30 days from the last date of study drug administration. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who fulfill any of the following criteria will be excluded:
- The presence of metastatic disease on imaging or laparoscopy.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever.
- Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
- Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.
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- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance or oral drug intake.
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.
Read the detailed description
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B
- Treatment will be administered on an outpatient basis.
- Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
- After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
- Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer
- Being tested
- FOLFIRINOX, Gemcitabine/nab-Paclitaxel, Radiation therapy, Capecitabine
- Keywords
- Resectable pancreatic cancer, Pancreatic Ductal Carcinoma
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOXDrug
Gemcitabine/nab-PaclitaxelDrug
Radiation therapyRadiation
CapecitabineDrug
Also called Xeloda
| Study group | Role | What they receive |
|---|---|---|
| Folfirinox-ARM A | Experimental | Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
* Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
* After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
* Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer Receives: Drug: FOLFIRINOX; Radiation: Radiation therapy; Drug: Capecitabine |
| Gemcitabine/nab-Paclitaxel- Arm B | Experimental | * Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
* Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
* After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
* Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer Receives: Drug: Gemcitabine/nab-Paclitaxel; Radiation: Radiation therapy; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate at 18 Month
Number of participants surviving after 18 months of study follow-up
Measured: 18 Month
Secondary outcomes (8)
Pathologic Complete Response Rate (pCR).
Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.
Measured: 18 Months
Overall Survival Rate
Overall survival rate at five years using Kaplan-Meier survival analysis
Measured: Baseline, 5 Years
Number of Participants With Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
Measured: Baseline, 28 Days
Surgical Morbidity Rate
Number of patients experiencing a specific surgery related morbidity
Measured: within 30 days of surgery
30-day Post-operative Mortality Rate
Number of patients who died following surgery.
Measured: 30 Days
Correlation of Biomarkers With PFS
Analysis of the correlation between selected bio-markers and progression free survival.
Measured: 2 Years
Rate of Pathologic Downstaging
The number of participants achieving a reduction in the pathological staging of the primary cancer.
Measured: 2 Years
Local Control Rate
The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Patrick Ryan, MD, Massachusetts General Hospital
- Investigators
- David Ryan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243007
- Sponsor's protocol ID
- 14-218
- Status last verified
- Apr 2017
- First submitted
- 15 Sep 2014
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02243007
- Acronym / sponsor ID
- 14-218
- Keywords
- Resectable pancreatic cancer, Pancreatic Ductal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.
Detailed description
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B
- Treatment will be administered on an outpatient basis.
- Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
- After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
- Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folfirinox-ARM A | Experimental | Drug: FOLFIRINOX, Radiation: Radiation therapy, Drug: CapecitabineUpon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel * Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days. * After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine. * Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer |
| Gemcitabine/nab-Paclitaxel- Arm B | Experimental | Drug: Gemcitabine/nab-Paclitaxel, Radiation: Radiation therapy, Drug: Capecitabine* Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel). * Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period. * After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine * Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Cytologic or histologic proof of pancreatic ductal carcinoma is required prior to study entry.
- No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan (or MRI with gadolinium and/or manganese) and laparoscopy. All patients must be staged with a physical exam, chest CT, abdominal CT with intravenous contrast (or abdominal MRI with gadolinium and/or manganese). Only potentially resectable patients are eligible. Potentially resectable is defined as a) no extrapancreatic disease, b) no evidence (on CT) of involvement of the celiac axis or SMA, c) no evidence (CT or MRI) of occlusion of the SMV or SMPV confluence, and d) no evidence of gross peritoneal or distant metastases by laparoscopy.
- Patients must be 18 years old or older. There will be no upper age restriction.
- ECOG Performance Status of 0 or 1 are eligible.
- Life expectancy of greater than 3 months.
Key exclusion criteria (11 listed)
- The presence of metastatic disease on imaging or laparoscopy.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever.
- Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
- Diagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last five years. Carcinoma in-situ is allowed.
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 |
|---|---|---|
| FOLFIRINOX | Drug | Folfirinox-ARM A |
| Gemcitabine/nab-Paclitaxel | Drug | Gemcitabine/nab-Paclitaxel- Arm B |
| Radiation therapy | Radiation | Folfirinox-ARM A, Gemcitabine/nab-Paclitaxel- Arm B |
| CapecitabineAlso: Xeloda | Drug | Folfirinox-ARM A, Gemcitabine/nab-Paclitaxel- Arm B |
Primary outcome
Survival Rate at 18 Month
Time frame: 18 Month
Number of participants surviving after 18 months of study follow-up
8 secondary outcomes
Pathologic Complete Response Rate (pCR).
Time frame: 18 Months
Overall Survival Rate
Time frame: Baseline, 5 Years
Number of Participants With Serious and Non-Serious Adverse Events
Time frame: Baseline, 28 Days
Surgical Morbidity Rate
Time frame: within 30 days of surgery
30-day Post-operative Mortality Rate
Time frame: 30 Days
Correlation of Biomarkers With PFS
Time frame: 2 Years
Rate of Pathologic Downstaging
Time frame: 2 Years
Local Control Rate
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Ryan, MD principal investigator
Massachusetts General Hospital
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 FOLFIRINOX, Gemcitabine/nab-Paclitaxel and Radiation therapy in people with Resectable Pancreatic Cancer and Pancreatic Ductal Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
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 17 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 May 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival Rate at 18 Month (time frame: 18 Month). 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 16 May 2017.