Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Folfirinox-ARM A 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 |
Drug: FOLFIRINOX
Radiation: Radiation therapy
Drug: Capecitabine
Other Names:
|
| Experimental: Gemcitabine/nab-Paclitaxel- Arm B 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 |
Drug: Gemcitabine/nab-Paclitaxel
Radiation: Radiation therapy
Drug: Capecitabine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Survival Rate at 18 Month [18 Month]
Number of participants surviving after 18 months of study follow-up
Secondary Outcome Measures
- Pathologic Complete Response Rate (pCR). [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.
- Overall Survival Rate [Baseline, 5 Years]
Overall survival rate at five years using Kaplan-Meier survival analysis
- Number of Participants With Serious and Non-Serious Adverse Events [Baseline, 28 Days]
Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
- Surgical Morbidity Rate [within 30 days of surgery]
Number of patients experiencing a specific surgery related morbidity
- 30-day Post-operative Mortality Rate [30 Days]
Number of patients who died following surgery.
- Correlation of Biomarkers With PFS [2 Years]
Analysis of the correlation between selected bio-markers and progression free survival.
- Rate of Pathologic Downstaging [2 Years]
The number of participants achieving a reduction in the pathological staging of the primary cancer.
- Local Control Rate [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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: David Ryan, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-218
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Period Title: Overall Study | ||
| STARTED | 4 | 3 |
| COMPLETED | 4 | 3 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B | Total |
|---|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine | Total of all reporting groups |
| Overall Participants | 4 | 3 | 7 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
63.4
|
71.9
|
65.6
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
25%
|
1
33.3%
|
2
28.6%
|
| Male |
3
75%
|
2
66.7%
|
5
71.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
4
100%
|
3
100%
|
7
100%
|
Outcome Measures
| Title | Survival Rate at 18 Month |
|---|---|
| Description | Number of participants surviving after 18 months of study follow-up |
| Time Frame | 18 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 4 | 3 |
| Count of Participants [Participants] |
2
50%
|
3
100%
|
| Title | Pathologic Complete Response Rate (pCR). |
|---|---|
| Description | 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. |
| Time Frame | 18 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response. |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
|
0
|
0
|
| Title | Overall Survival Rate |
|---|---|
| Description | Overall survival rate at five years using Kaplan-Meier survival analysis |
| Time Frame | Baseline, 5 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study terminated before endpoint was reached, no data available |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
| Title | Number of Participants With Serious and Non-Serious Adverse Events |
|---|---|
| Description | Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days |
| Time Frame | Baseline, 28 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 4 | 3 |
| Serious Adverse Events |
0
0%
|
2
66.7%
|
| Other Adverse Events |
4
100%
|
3
100%
|
| Title | Surgical Morbidity Rate |
|---|---|
| Description | Number of patients experiencing a specific surgery related morbidity |
| Time Frame | within 30 days of surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study ended prematurely, no results available |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
|
0
|
0
|
| Title | 30-day Post-operative Mortality Rate |
|---|---|
| Description | Number of patients who died following surgery. |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study ended prematurely, no results available |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
|
0
|
0
|
| Title | Correlation of Biomarkers With PFS |
|---|---|
| Description | Analysis of the correlation between selected bio-markers and progression free survival. |
| Time Frame | 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not available. Study was terminated before endpoint was able to be evaluated |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
|
0
|
0
|
| Title | Rate of Pathologic Downstaging |
|---|---|
| Description | The number of participants achieving a reduction in the pathological staging of the primary cancer. |
| Time Frame | 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not available. Study was terminated before endpoint was able to be evaluated |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
|
0
|
0
|
| Title | Local Control Rate |
|---|---|
| Description | 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. |
| Time Frame | 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not available. Study was terminated before endpoint was able to be evaluated |
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B |
|---|---|---|
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine |
| Measure Participants | 0 | 0 |
|
0
|
0
|
Adverse Events
| Time Frame | Toxicity was assessed on day 1 of each cycle for the FOLFIRINOX arm and on Day 1, 8, 15 of each cycle for the Gem/Nab-P arm while being treated. Toxicity was assessed weekly during neoadjuvant radiation treatment and Capecitabine. Toxicity was planned to be assessed every 6 months during the first 3 years of post treatment follow-up. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports. | |||
| Arm/Group Title | Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B | ||
| Arm/Group Description | 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 FOLFIRINOX Radiation therapy 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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine | ||
All Cause Mortality |
||||
| Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/4 (50%) | 0/3 (0%) | ||
Serious Adverse Events |
||||
| Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 2/3 (66.7%) | ||
| Investigations | ||||
| Neutrophil count decreased | 0/4 (0%) | 1/3 (33.3%) | ||
| Blood bilirubin increased | 0/4 (0%) | 1/3 (33.3%) | ||
| Vascular disorders | ||||
| hypotension | 0/4 (0%) | 1/3 (33.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Folfirinox-ARM A | Gemcitabine/Nab-Paclitaxel- Arm B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 3/3 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Hemolytic uremic syndrome | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Eye disorders | ||||
| Dry eye | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Eye disorders - Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Eye pain | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Optic nerve disorder | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/4 (75%) | 5 | 3/3 (100%) | 3 |
| Constipation | 1/4 (25%) | 1 | 2/3 (66.7%) | 3 |
| Diarrhea | 3/4 (75%) | 7 | 2/3 (66.7%) | 3 |
| Flatulence | 2/4 (50%) | 3 | 0/3 (0%) | 0 |
| Gastrointestinal disorders - Other, specify | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Hemorrhoids | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Malabsorption | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Mucositis oral | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Nausea | 3/4 (75%) | 6 | 2/3 (66.7%) | 6 |
| Vomiting | 1/4 (25%) | 1 | 1/3 (33.3%) | 2 |
| General disorders | ||||
| Edema limbs | 0/4 (0%) | 0 | 2/3 (66.7%) | 2 |
| Fatigue | 4/4 (100%) | 6 | 3/3 (100%) | 4 |
| Fever | 1/4 (25%) | 1 | 2/3 (66.7%) | 2 |
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Infections and infestations | ||||
| Infections and infestations - Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Bruising | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 2/4 (50%) | 2 | 1/3 (33.3%) | 2 |
| Aspartate aminotransferase increased | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 |
| Blood bilirubin increased | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Neutrophil count decreased | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 |
| Platelet count decreased | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Weight loss | 2/4 (50%) | 2 | 1/3 (33.3%) | 2 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 3/4 (75%) | 4 | 2/3 (66.7%) | 2 |
| Dehydration | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Hypokalemia | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Hyponatremia | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Muscle weakness lower limb | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Musculoskeletal and connective tissue disorder - Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Myalgia | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Pain in extremity | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Nervous system disorders | ||||
| Dizziness | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Dysesthesia | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Dysgeusia | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Dysphasia | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Headache | 2/4 (50%) | 2 | 0/3 (0%) | 0 |
| Paresthesia | 1/4 (25%) | 2 | 0/3 (0%) | 0 |
| Peripheral motor neuropathy | 1/4 (25%) | 3 | 0/3 (0%) | 0 |
| Peripheral sensory neuropathy | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Spasticity | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Insomnia | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal and urinary disorders - Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Urine discoloration | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Reproductive system and breast disorders | ||||
| Menorrhagia | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Dyspnea | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Sore throat | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Wheezing | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 |
| Pruritus | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 |
| Rash maculo-papular | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 |
| Skin and subcutaneous tissue disorders - Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
| Skin/subcutaneous tissue disorders; Other, specify | 1/4 (25%) | 1 | 0/3 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | David P. Ryan, MD |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 6177240245 |
| dpryan@mgh.harvard.edu |
- 14-218