- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243007
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Folfirinox-ARM A
Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel
|
Other Names:
|
Experimental: Gemcitabine/nab-Paclitaxel- Arm B
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival Rate at 18 Month
Time Frame: 18 Month
|
Number of participants surviving after 18 months of study follow-up
|
18 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Complete Response Rate (pCR).
Time Frame: 18 Months
|
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.
|
18 Months
|
Overall Survival Rate
Time Frame: Baseline, 5 Years
|
Overall survival rate at five years using Kaplan-Meier survival analysis
|
Baseline, 5 Years
|
Number of Participants With Serious and Non-Serious Adverse Events
Time Frame: Baseline, 28 Days
|
Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
|
Baseline, 28 Days
|
Surgical Morbidity Rate
Time Frame: within 30 days of surgery
|
Number of patients experiencing a specific surgery related morbidity
|
within 30 days of surgery
|
30-day Post-operative Mortality Rate
Time Frame: 30 Days
|
Number of patients who died following surgery.
|
30 Days
|
Correlation of Biomarkers With PFS
Time Frame: 2 Years
|
Analysis of the correlation between selected bio-markers and progression free survival.
|
2 Years
|
Rate of Pathologic Downstaging
Time Frame: 2 Years
|
The number of participants achieving a reduction in the pathological staging of the primary cancer.
|
2 Years
|
Local Control Rate
Time Frame: 2 Years
|
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.
|
2 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Ryan, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Pancreatic Neoplasms
- Carcinoma, Ductal
- Carcinoma, Pancreatic Ductal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
- Capecitabine
- Folfirinox
Other Study ID Numbers
- 14-218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Resectable Pancreatic Cancer
-
UNC Lineberger Comprehensive Cancer CenterRecruitingPancreatic Neoplasms | Pancreas Adenocarcinoma | Pancreatic Cancer Resectable | Cancer of Pancreas | Pancreatic Cancer Non-resectable | Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Cancer, AdultUnited States
-
National Cancer Institute (NCI)RecruitingPancreatic Acinar Cell Carcinoma | Pancreatic Adenosquamous Carcinoma | Pancreatic Squamous Cell Carcinoma | Resectable Pancreatic Acinar Cell Carcinoma | Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Adenosquamous Carcinoma | Resectable Pancreatic CarcinomaUnited States
-
Kimberly Perez, MDNovartisTerminatedPancreatic Cancer | Pancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Borderline Resectable Pancreatic AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Gangnam Severance HospitalCompletedResectable Pancreatic AdenocarcinomaKorea, Republic of
-
M.D. Anderson Cancer CenterRecruitingBorderline Resectable Pancreatic Adenocarcinoma | Stage IA Pancreatic Cancer AJCC v8 | Stage IB Pancreatic Cancer AJCC v8 | Stage IIA Pancreatic Cancer AJCC v8 | Stage IIB Pancreatic Cancer AJCC v8 | Resectable Pancreatic AdenocarcinomaUnited States
-
Wakayama Medical UniversityRecruitingResectable Pancreatic Body/Tail CarcinomaJapan
-
Lawson Health Research InstituteLondon Health Sciences FoundationNot yet recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Adenocarcinoma
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Pancreatic Cancer AJCC v8 | Borderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
Clinical Trials on Capecitabine
-
Sun Yat-sen UniversityChengdu Biostar PharmaceuticalsNot yet recruitingBreast Neoplasms | Locally Advanced or Metastatic Breast CancerChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Hoffmann-La RocheCompletedBreast Cancer, Colorectal CancerNew Zealand, Australia, United Kingdom
-
Samsung Medical CenterCompletedAdvanced or Recurrent Esophageal Squamous Cell CarcinomaKorea, Republic of
-
Fudan UniversityCompletedMetastatic Breast CancerChina
-
Cancer Institute and Hospital, Chinese Academy...Hoffmann-La RocheUnknownCarcinoma, Invasive Ductal, BreastChina
-
Binghe XuHoffmann-La RocheUnknownSkin Diseases | Neoplasms by Site | Breast Neoplasms | Breast Diseases | Neoplasm MetastasisChina
-
Jules Bordet InstituteCompletedBreast Cancer | Elderly PatientsBelgium
-
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
-
Jiangxi Provincial Cancer HospitalNot yet recruitingNasopharyngeal Carcinoma | Maintenance Therapy | High-Risk Cancer