Trial Outcomes & Findings for Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer (NCT NCT02243007)

NCT ID: NCT02243007

Last Updated: 2017-05-16

Results Overview

Number of participants surviving after 18 months of study follow-up

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 18 Month
• Results posted on: 2017-05-16

Participant Flow

Participant milestones

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

Baseline characteristics by cohort

Measure	Folfirinox-ARM A n=4 Participants 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	Gemcitabine/Nab-Paclitaxel- Arm B n=3 Participants * 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 n=7 Participants Total of all reporting groups
Age, Continuous	63.4 years n=5 Participants	71.9 years n=7 Participants	65.6 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 Month

Number of participants surviving after 18 months of study follow-up

Outcome measures

Measure	Folfirinox-ARM A n=4 Participants 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	Gemcitabine/Nab-Paclitaxel- Arm B n=3 Participants * 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
Survival Rate at 18 Month	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 18 Months

Population: No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.

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.

Outcome measures

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
Pathologic Complete Response Rate (pCR).	0	0

SECONDARY outcome

Timeframe: Baseline, 5 Years

Population: Study terminated before endpoint was reached, no data available

Overall survival rate at five years using Kaplan-Meier survival analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 28 Days

Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days

Outcome measures

Measure	Folfirinox-ARM A n=4 Participants 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	Gemcitabine/Nab-Paclitaxel- Arm B n=3 Participants * 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
Number of Participants With Serious and Non-Serious Adverse Events Serious Adverse Events	0 participants	2 participants
Number of Participants With Serious and Non-Serious Adverse Events Other Adverse Events	4 participants	3 participants

SECONDARY outcome

Timeframe: within 30 days of surgery

Population: Study ended prematurely, no results available

Number of patients experiencing a specific surgery related morbidity

Outcome measures

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
Surgical Morbidity Rate	0	0

SECONDARY outcome

Timeframe: 30 Days

Population: Study ended prematurely, no results available

Number of patients who died following surgery.

Outcome measures

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
30-day Post-operative Mortality Rate	0	0

SECONDARY outcome

Timeframe: 2 Years

Population: Data not available. Study was terminated before endpoint was able to be evaluated

Analysis of the correlation between selected bio-markers and progression free survival.

Outcome measures

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
Correlation of Biomarkers With PFS	0	0

SECONDARY outcome

Timeframe: 2 Years

Population: Data not available. Study was terminated before endpoint was able to be evaluated

The number of participants achieving a reduction in the pathological staging of the primary cancer.

Outcome measures

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
Rate of Pathologic Downstaging	0	0

SECONDARY outcome

Timeframe: 2 Years

Population: Data not available. Study was terminated before endpoint was able to be evaluated

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.

Outcome measures

Measure	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 FOLFIRINOX Radiation therapy Capecitabine	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 Gemcitabine/nab-Paclitaxel Radiation therapy Capecitabine
Local Control Rate	0	0

Adverse Events

Folfirinox-ARM A

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Gemcitabine/Nab-Paclitaxel- Arm B

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Folfirinox-ARM A n=4 participants at risk 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	Gemcitabine/Nab-Paclitaxel- Arm B n=3 participants at risk * 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
Vascular disorders hypotension	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Neutrophil count decreased	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Blood bilirubin increased	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.

Other adverse events

Measure	Folfirinox-ARM A n=4 participants at risk 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	Gemcitabine/Nab-Paclitaxel- Arm B n=3 participants at risk * 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
Gastrointestinal disorders Abdominal pain	75.0% 3/4 • Number of events 5 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	100.0% 3/3 • Number of events 3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Injury, poisoning and procedural complications Ankle fracture	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Metabolism and nutrition disorders Anorexia	75.0% 3/4 • Number of events 4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	66.7% 2/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Blood bilirubin increased	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Injury, poisoning and procedural complications Bruising	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	66.7% 2/3 • Number of events 3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Diarrhea	75.0% 3/4 • Number of events 7 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	66.7% 2/3 • Number of events 3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Eye disorders Dry eye	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Dysesthesia	25.0% 1/4 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Dysphasia	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
General disorders Edema limbs	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	66.7% 2/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Eye disorders Eye disorders - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Eye disorders Eye pain	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
General disorders Fatigue	100.0% 4/4 • Number of events 6 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	100.0% 3/3 • Number of events 4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
General disorders Fever	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	66.7% 2/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Flatulence	50.0% 2/4 • Number of events 3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Headache	50.0% 2/4 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Blood and lymphatic system disorders Hemolytic uremic syndrome	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Hemorrhoids	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Infections and infestations Infections and infestations - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Malabsorption	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Reproductive system and breast disorders Menorrhagia	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Mucositis oral	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Nausea	75.0% 3/4 • Number of events 6 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	66.7% 2/3 • Number of events 6 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Neutrophil count decreased	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Eye disorders Optic nerve disorder	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Paresthesia	25.0% 1/4 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Peripheral motor neuropathy	25.0% 1/4 • Number of events 3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Platelet count decreased	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Renal and urinary disorders Renal and urinary disorders - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Nervous system disorders Spasticity	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Renal and urinary disorders Urine discoloration	0.00% 0/4 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Investigations Weight loss	50.0% 2/4 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	33.3% 1/3 • Number of events 2 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
Respiratory, thoracic and mediastinal disorders Wheezing	25.0% 1/4 • Number of events 1 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.	0.00% 0/3 • 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. Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.

Additional Information

David P. Ryan, MD

Massachusetts General Hospital

Phone: 6177240245

Email: dpryan@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place