Phase II Study of Preoperative FOLFIRINOX Versus Gemcitab... | NCT02243007

Label	Type	Description	Intervention Names
Folfirinox-ARM A	Experimental	Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days. After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine. Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer	Drug: FOLFIRINOX Radiation: Radiation therapy Drug: Capecitabine
Gemcitabine/nab-Paclitaxel- Arm B	Experimental	Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel). Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period. After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer	Drug: Gemcitabine/nab-Paclitaxel Radiation: Radiation therapy Drug: Capecitabine

Name	Type	Description	Arm Group Labels	Other Names
FOLFIRINOX	Drug		Folfirinox-ARM A
Gemcitabine/nab-Paclitaxel

Measure	Description	Time Frame
Survival Rate at 18 Month	Number of participants surviving after 18 months of study follow-up	18 Month

Measure	Description	Time Frame
Pathologic Complete Response Rate (pCR).	Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.	18 Months
Overall Survival Rate

Eligibility Module

Eligibility 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.

Name	Affiliation	Role
David Ryan, MD	Massachusetts General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

ID	Title	Description
FG000	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

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0004 BG0013 BG0027

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Survival Rate at 18 Month

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

Posted

Count of Participants

Participants

18 Month

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG0004 OG0013

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0013

Secondary

Pathologic Complete Response Rate (pCR).

Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.

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

Posted

18 Months

ID	Title	Description
OG000	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
OG001	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

Secondary

Overall Survival Rate

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

Study terminated before endpoint was reached, no data available

Posted

Baseline, 5 Years

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With Serious and Non-Serious Adverse Events

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

Posted

Number

participants

Baseline, 28 Days

ID	Title	Description
OG000	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
OG001	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

Secondary

Surgical Morbidity Rate

Number of patients experiencing a specific surgery related morbidity

Study ended prematurely, no results available

Posted

within 30 days of surgery

ID	Title	Description
OG000	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
OG001	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

Secondary

30-day Post-operative Mortality Rate

Number of patients who died following surgery.

Study ended prematurely, no results available

Posted

30 Days

ID	Title	Description
OG000	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
OG001	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

Secondary

Correlation of Biomarkers With PFS

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

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

Posted

2 Years

ID	Title	Description
OG000	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
OG001	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

Secondary

Rate of Pathologic Downstaging

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

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

Posted

2 Years

ID	Title	Description
OG000	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
OG001	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

Secondary

Local Control Rate

The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.

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

Posted

2 Years

ID	Title	Description
OG000	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
OG001	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

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	2	4	0	4	4	4
EG001	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	0	3	2	3	3	3

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected4 at risk EG0011 affected3 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0005 events3 affected4 at risk EG0013 events3 affected3 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected4 at risk EG0012 events1 affected3 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk
Ankle fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 events3 affected4 at risk EG0012 events2 affected3 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected3 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0013 events2 affected3 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 events3 affected4 at risk EG0013 events2 affected3 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected3 at risk
Dry eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Dysesthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected3 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Dysphasia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Edema limbs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events2 affected3 at risk
Eye disorders - Other, specify	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Eye pain	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events4 affected4 at risk EG0014 events3 affected3 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events2 affected3 at risk
Flatulence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events2 affected4 at risk EG0010 events0 affected3 at risk
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected4 at risk EG0010 events0 affected3 at risk
Hemolytic uremic syndrome	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Infections and infestations - Other, specify	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Malabsorption	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Menorrhagia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 events3 affected4 at risk EG0016 events2 affected3 at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected3 at risk
Optic nerve disorder	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 events1 affected4 at risk EG0010 events0 affected3 at risk
Peripheral motor neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 events1 affected4 at risk EG0010 events0 affected3 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0011 events1 affected3 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0012 events1 affected3 at risk
Renal and urinary disorders - Other, specify	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Skin/subcutaneous tissue disorders; Other, specify	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Spasticity	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk
Urine discoloration	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 events0 affected4 at risk EG0011 events1 affected3 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0012 events1 affected3 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 events2 affected4 at risk EG0012 events1 affected3 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 events1 affected4 at risk EG0010 events0 affected3 at risk

ID	Term
D044584	Carcinoma, Ductal
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018299	Neoplasms, Ductal, Lobular, and Medullary
D010190	Pancreatic Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
C000627770	folfirinox
D011878	Radiotherapy
D000069287	Capecitabine

ID	Term
D013812	Therapeutics
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides