Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PANC0015 | Other Identifier | OnCore | |
| NCI-2013-01658 | Other Identifier | NCI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.
Primary Objective:
To determine progression free survival for mFFX +/- SBRT.
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified FOLFIRINOX | Active Comparator | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin. |
|
| Modified FOLFIRINOX plus Stereotactic Body Radiotherapy | Experimental | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation. | 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local Progression-free Survival (Local PFS) | Local progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation. |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Metastatic disease
Prior radiotherapy to the upper abdomen/liver.
Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX.
Age < 18 years
Uncontrolled intercurrent illness including, but not limited to:
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
Pregnant or lactating
Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) for duration of the study
Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Male subjects who are unwilling or unable to use effective contraception for duration of the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel T Chang | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 60153 | United States | ||
| UCSF |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Modified FOLFIRINOX | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Irinotecan | Drug | Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle. |
|
|
| Leucovorin | Drug | Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle. |
|
|
| 5FU | Drug | 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle. |
|
|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days. |
|
| 38 months |
| Progression-free Survival (PFS) at 1 Year | Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment. The outcome is reported as a number without dispersion. | 1 year |
| Metastasis-free Survival (MFS) | Metastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation. | 62 months |
| Overall Survival (OS) | The effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation. | 62 months |
| Grade 2 or Greater Gastrointestinal (GI) Toxicity | Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is reported as numbers without dispersion. All-cause Mortality mFFX 7 SBRT 8 | 3 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
| Loyola University | Maywood | Illinois | 60153 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98107 | United States |
| BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| FG001 | Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Only participants that received study treatment are included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Modified FOLFIRINOX | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
|
| BG001 | Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Progression-free Survival (PFS) | Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation. | Posted | Median | Standard Deviation | months | 38 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Local Progression-free Survival (Local PFS) | Local progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation. | Posted | Median | Standard Deviation | months | 38 months |
| |||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) at 1 Year | Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment. The outcome is reported as a number without dispersion. | Posted | Count of Participants | Participants | 1 year |
| ||||||||||||||||||||||||||||||||
| Secondary | Metastasis-free Survival (MFS) | Metastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation. | Posted | Median | Standard Deviation | months | 62 months |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation. | Posted | Median | Standard Deviation | months | 62 months |
| |||||||||||||||||||||||||||||||
| Secondary | Grade 2 or Greater Gastrointestinal (GI) Toxicity | Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is reported as numbers without dispersion. All-cause Mortality mFFX 7 SBRT 8 | Analysis group is those participants that received at least one dose of the Modified FOLFIRINOX (mFFX) chemotherapy regimen. | Posted | Number | Related adverse events | 3 months |
|
up to 62 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified FOLFIRINOX | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
| 7 | 12 | 5 | 12 | 12 | 12 |
| EG001 | Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy | Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
| 8 | 13 | 7 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other, hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, abdominal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bleed (hemorrhage), gastrointestinal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bleed (hemorrhage), gastrointestinal upper | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, intractable (due to disease progression) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection - Klebsiella pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Other, renal failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell (WBC) count elevated (leukocytosis) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ringing in the ears (tinnitus) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye inflammation (scleral disorder) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abnormal sensation in the mouth (oral dysesthesia) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bleed (hemorrhage), gastrointestinal upper | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fluid in abdomen (ascites) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroparesis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage, anal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage, hemorrhoidal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Indigestion (dyspepsia) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Inflammation of the lining of the stomach (gastritis) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral inflammation (mucositis) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, excess in the stool (steatorrhea) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, stool discolored, clay color | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, abdominal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, rectal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, stomach | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Swallowing difficulty (dysphagia) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema, localized | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema, peripheral | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General feeling of discomfort (malaise) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion-related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritability | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, abdominal | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, chest, non-cardiac | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Clot in portal vein (thrombosis) | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash, papulopustular | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac troponin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Gamma-glutamyl transferase (GGT) increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| International normalized ratio (INR) increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytosis | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Other, Creatinine decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Other, Neutrophil count increase | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Other, Protein total decrease | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Other, WBC morphology | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Reduced red blood cells or hemoglobin (anemia) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased appetite (anorexia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, Phosphate increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle pain (myalgia) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, flank | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bad taste in mouth (dysgeusia) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Drowsiness, unusual (somnolence) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Excessive sleep (hypersomnia) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Feeling faint (presyncope) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nerve damage or injury (neuropathy) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nerve damage or injury (neuropathy), peripheral | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nerve damage or injury (neuropathy), peripheral sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nerve tingling (paresthesia) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nosebleed (epistaxis) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, muscle weakness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Reduced albumin in the blood (hypoalbuminemia) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Slow or slurred speech (dysarthria) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tiredness (fatigue) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Amnesia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Difficulty sleeping (insomnia) | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Excess protein in urine (proteinuria) | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema, pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Labored breathing (dyspnea) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung collaspe (atelectasis) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Excessive sweating (hyperhidrosis) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hair loss, immune-realted (alopecia) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Itch (pruritus) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, atypical junctional nevus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, axilla boil | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, aypical melanocytic proliferation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, bump on right upper extremity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, deep mobile mass | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, medial right nodule on right upper extremity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, melanoma in-situ | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, small nodule on right upper extremity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash, maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Wong | Stanford Medicine at Stanford University | 650-498-8495 | swong8@stanford.edu |
| Sep 30, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2019 | Jun 10, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| C584112 | irinotecan sucrosofate |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|