FOLFOX Plus Regorafenib in Patients With Unresectable or... | NCT01913639

Status Module

Name	Class
Bayer	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFOX Plus Regorafenib	Experimental	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.	Drug: Regorafenib Drug: 5-Fluorouracil Drug: Leucovorin Drug: Oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib	Drug		FOLFOX Plus Regorafenib	(Bay 73-4506)
5-Fluorouracil

Measure	Description	Time Frame
Progression Free Survival (PFS)		6 months

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival will be measured from the start of treatment to death or last follow-up and will be estimated using the Kaplan-Meier method	2 years
Overall Response Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must have histologically or cytologically confirmed metastatic or unresectable esophageal, gastroesophageal junction or gastric adenocarcinoma.
Patient must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease. Minimum indicator lesion size = 10 mm by helical CT or = 20 mm by conventional techniques. Pathological nodes must be = 15 mm by the short axis to be considered measurable.
Subject must be able to swallow and retain oral medication
Age 18 years or older.
Karnofsky performance status > or = to 70%
Peripheral neuropathy ≤ grade 1
Hematologic (minimal values) White blood cell count > or = to 3000/mm3© Absolute neutrophil count > 1500 cells/ mm3 Hemoglobin > or = to 8.0 g/dl Platelet count > or = to 90,000 / mm3 Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer). Patients with alkaline phosphatase elevation secondary to the bony metastases rather than liver dysfunction may proceed with treatment on protocol after discussion with the principal investigator.
Serum creatinine ≤ 1.5 x the ULN
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test..
Patients with prior deep vein thrombosis (DVT) or pulmonary embolism (PE) currently on an stable anticoagulation regimen with low molecular weight heparin (LMWH) or rivaroxaban will be permitted.

Exclusion Criteria:

Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management.
Active or clinically significant cardiac disease including:
Congestive heart failure - New York Heart Association (NYHA) > Class II.
Active coronary artery disease.
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
Evidence or history of bleeding diathesis or coagulopathy.
Any hemorrhage or bleeding event ≥ NCI CTCAE version 4.0 Grade 3 within 4 weeks prior to start of study medication.
Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.
Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
Patient may not have received prior chemotherapy for metastatic or unresectable disease.
Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration.
Patient may not have received prior 5-Fluorouracil, Leucovorin, Oxaliplatin or regorafenib. Patient may have received prior radiosensitizing doses of 5Fu if more than 6 months have elapsed between the end of adjuvant therapy and registration.
Patient may not have had major surgical procedure within 4 weeks of registration.
Patient may not have had radiation within 2 weeks of registration.

Name	Affiliation	Role
Yelena Janjigian, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memoral Sloan Kettering Cancer Center		Basking Ridge	New Jersey		United States
Memorial Sloan Kettering Cancer Center @ Suffolk

Label	URL
Memorial Sloan Kettering Cancer Center	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Apr 18, 2017

Arm/Group Information

ID	Title	Description
BG000	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.

Units	Counts
Participants	BG00039

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)

Posted

Number

95% Confidence Interval

percentage of participants

6 months

ID	Title	Description
OG000	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.

Units	Counts
Participants	OG00039

Title

Denominators

Categories

Title	Measurements
	OG00053(38 to 71)

Secondary

Overall Survival (OS)

Overall survival will be measured from the start of treatment to death or last follow-up and will be estimated using the Kaplan-Meier method

Posted

Median

95% Confidence Interval

months

2 years

ID	Title	Description
OG000	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.

Units	Counts
Participants

Secondary

Overall Response Rate

This is defined as the percentage of patients who have achieved either an objective complete or partial target lesion response that is confirmed on the RECIST 1.1 criteria. Complete or partial responses will be confirmed with repeat CT evaluation after 4 weeks.

Posted

Number

95% Confidence Interval

percentage of participants with CR or PR

4 weeks

ID	Title	Description
OG000	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.

Units	Counts
Participants

Secondary

Participants Evaluated for Toxicity

Adverse events will be determined as per the NCI Common Toxicity Criteria, version 4.0. Toxicity during cycle 1 and subsequent cycles will be reported.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.

Units	Counts
Participants

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	FOLFOX Plus Regorafenib	Regorafenib 160 mg daily on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets + mFOLFOX on Day 1 and Day 15 of each cycle. Each cycle consists of 28 days. All patients will receive systemic chemotherapy with the mFOLFOX regimen and regorafenib. The specific version of the FOLFOX regimen used at MSKCC is mFOLFOX6. mFOLFOX6 will be given on Day 1 of each cycle. Patients will receive Oxaliplatin 85 mg/m2 IV (over 120 minutes), leucovorin 400 mg/m2 IV (over 120 minutes), 5-FU 400 mg/m2 IVP, and 5-FU 1200 mg/m2/day CIVI x 2 days, every two weeks. Treatment will be performed on the scheduled day ± 7 days. In case of discontinuation of FOLFOX due to cumulative toxicity and administration as a single agent during the study, regorafenib for patient convenience will be administered 160 mg daily for 3 weeks on/1 week off. The 3 weeks on/1 week off schedule is supported by the single agent regorafenib data in colon cancer and GIST.	30	39	17	39	36	39

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0003 affected39 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0009 affected39 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Chest pain - cardiac	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0005 affected39 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected39 at risk
Death NOS	General disorders	Systematic Assessment	EG0001 affected39 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected39 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected39 at risk
Fatigue	General disorders	Systematic Assessment	EG0003 affected39 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected39 at risk
Fever	General disorders	Systematic Assessment	EG0004 affected39 at risk
Gastrointestinal disorders -Other, specify	Gastrointestinal disorders	Systematic Assessment	EG0002 affected39 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0001 affected39 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0002 affected39 at risk
Left ventricular systolic dysfunction	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Lipase increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Muscle weakness left-sided	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0003 affected39 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0002 affected39 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 affected39 at risk
Pain	General disorders	Systematic Assessment	EG0001 affected39 at risk
Paresthesia	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected39 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected39 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Right ventricular dysfunction	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Serum amylase increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0002 affected39 at risk
Skin & subcutaneous tissue disorders Other, spec	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Small intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0002 affected39 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0002 affected39 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0004 affected39 at risk
Weight loss	Investigations	Systematic Assessment	EG0001 affected39 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Fatigue	General disorders	Systematic Assessment	EG00031 affected39 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00028 affected39 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG00028 affected39 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG00027 affected39 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG00027 affected39 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG00025 affected39 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00023 affected39 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG00023 affected39 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00021 affected39 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG00020 affected39 at risk
Mucositis oral	Gastrointestinal disorders	Systematic Assessment	EG00014 affected39 at risk
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00014 affected39 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG00013 affected39 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG00012 affected39 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00012 affected39 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00011 affected39 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00011 affected39 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00010 affected39 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0009 affected39 at risk
Weight loss	Investigations	Systematic Assessment	EG0009 affected39 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0008 affected39 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0007 affected39 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 affected39 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 affected39 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 affected39 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0004 affected39 at risk
Edema limbs	General disorders	Systematic Assessment	EG0004 affected39 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0004 affected39 at risk
Paresthesia	Nervous system disorders	Systematic Assessment	EG0004 affected39 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 affected39 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected39 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0003 affected39 at risk
Fever	General disorders	Systematic Assessment	EG0003 affected39 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0003 affected39 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected39 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 affected39 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0002 affected39 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0002 affected39 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0002 affected39 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected39 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0002 affected39 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected39 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected39 at risk
INR increased	Investigations	Systematic Assessment	EG0002 affected39 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected39 at risk
Pain	General disorders	Systematic Assessment	EG0002 affected39 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected39 at risk
Small intestinal mucositis	Gastrointestinal disorders	Systematic Assessment	EG0002 affected39 at risk

ID	Term
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
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
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Term
C559147	regorafenib
D005472	Fluorouracil
D002955	Leucovorin
D000077150	Oxaliplatin