Non-Operative Radiation Management of Adenocarcinoma of t... | NCT02641691

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Experimental	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX	Radiation: Radiation Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil

Name	Type	Description	Arm Group Labels	Other Names
Radiation	Radiation		Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete Response Rate	Criteria for complete clinical response: No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer No radiographic evidence of tumor on DRE Substantial downsizing on MRI No suspicious mesorectal lymph nodes on MRI Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) Criteria for no significant clinical response: Residual disease by DRE, endoscopy or MR. Increase in primary tumor size upon clinical exam or imaging Any new lesions	1 year

Secondary Outcomes

Measure	Description	Time Frame
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).	Baseline
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI and/or endorectal ultrasound
Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a
ECOG performance status 0-2
At least 18 years of age
Adequate bone marrow function defined as:
- ANC > 1,500 cells/mm3
- Hgb > 8 g/dl
- platelets >100,000 cells/mm3
Women of childbearing 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 participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

No clinically detectable (MR, endoscopy or DRE) tumor present
Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
Any evidence of disease from another malignancy or history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix). Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible.
Currently receiving any investigational agents.
A history of allergic reaction attributed to compounds of similar chemical or biologic composition to 5FU, oxaliplatin, or leucovorin.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Name	Affiliation	Role
Hyun Kim, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

PubMed Identifier	Type	Citation	Retractions
34001462	Derived	Kim H, Pedersen K, Olsen JR, Mutch MG, Chin RI, Glasgow SC, Wise PE, Silviera ML, Tan BR, Wang-Gillam A, Lim KH, Suresh R, Amin M, Huang Y, Henke LE, Park H, Ciorba MA, Badiyan S, Parikh PJ, Roach MC, Hunt SR. Nonoperative Rectal Cancer Management With Short-Course Radiation Followed by Chemotherapy: A Nonrandomized Control Trial. Clin Colorectal Cancer. 2021 Sep;20(3):e185-e193. doi: 10.1016/j.clcc.2021.03.003. Epub 2021 Apr 7.

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

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	Jun 1, 2018

Arm/Group Information

ID	Title	Description
BG000	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Units	Counts
Participants	BG00020

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

Complete Response Rate

Criteria for complete clinical response:
- No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer
- No radiographic evidence of tumor on DRE
- Substantial downsizing on MRI
- No suspicious mesorectal lymph nodes on MRI
- Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
Criteria for no significant clinical response:
- Residual disease by DRE, endoscopy or MR.
- Increase in primary tumor size upon clinical exam or imaging
- Any new lesions

1 participant was not evaluable for this outcome measure as they were removed for an adverse event

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Units	Counts
Participants	OG00019

Title

Denominators

Categories

Title	Measurements
	OG00012

Secondary

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	0=Not at All	-Participant is asked about specific well-being in the past 7 days
OG001	1=A Little Bit	-Participant is asked about specific well-being in the past 7 days
OG002	2=Somewhat	-Participant is asked about specific well-being in the past 7 days
OG003	3=Quite a Bit	-Participant is asked about specific well-being in the past 7 days
OG004	4=Very Much	-Participant is asked about specific well-being in the past 7 days

Secondary

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

Posted

Count of Participants

Participants

Completion of chemoradiation (approximately 112 days)

ID	Title	Description
OG000	0=Not at All	-Participant is asked about specific well-being in the past 7 days
OG001	1=A Little Bit	-Participant is asked about specific well-being in the past 7 days
OG002	2=Somewhat	-Participant is asked about specific well-being in the past 7 days
OG003	3=Quite a Bit	-Participant is asked about specific well-being in the past 7 days

Secondary

Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire

-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.

Posted

Count of Participants

Participants

10-14 months after chemoradiation (approximately 16-20 months)

ID	Title	Description
OG000	0=Not at All	-Participant is asked about specific well-being in the past 7 days
OG001	1=A Little Bit	-Participant is asked about specific well-being in the past 7 days
OG002	2=Somewhat	-Participant is asked about specific well-being in the past 7 days
OG003	3=Quite a Bit	-Participant is asked about specific well-being in the past 7 days

Secondary

Number of Any Grade 3 or Higher Toxicities

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Posted

Count of Participants

Participants

From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)

ID	Title	Description
OG000	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Units	Counts

Secondary

Number of Post Chemotherapy Grade 3 or Higher Toxicities

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

Posted

Count of Participants

Participants

Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)

ID	Title	Description
OG000	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Secondary

Quality of Anorectal Function as Measured by the FACT-C Questionnaire

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	0=Not at All	-Participant is asked about specific well-being in the past 7 days
OG001	1=A Little Bit	-Participant is asked about specific well-being in the past 7 days
OG002	2=Somewhat	-Participant is asked about specific well-being in the past 7 days
OG003	3=Quite a Bit	-Participant is asked about specific well-being in the past 7 days
OG004	4=Very Much	-Participant is asked about specific well-being in the past 7 days

Secondary

Quality of Anorectal Function as Measured by the FACT-C Questionnaire

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

Posted

Count of Participants

Participants

Completion of chemoradiation (approximately 112 days)

ID	Title	Description
OG000	0=Not at All	-Participant is asked about specific well-being in the past 7 days
OG001	1=A Little Bit	-Participant is asked about specific well-being in the past 7 days
OG002	2=Somewhat	-Participant is asked about specific well-being in the past 7 days
OG003	3=Quite a Bit	-Participant is asked about specific well-being in the past 7 days
OG004

Secondary

Quality of Anorectal Function as Measured by the FACT-C Questionnaire

-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

Posted

Count of Participants

Participants

10-14 months after chemoradiation (approximately 16-20 months)

ID	Title	Description
OG000	0=Not at All	-Participant is asked about specific well-being in the past 7 days
OG001	1=A Little Bit	-Participant is asked about specific well-being in the past 7 days
OG002	2=Somewhat	-Participant is asked about specific well-being in the past 7 days
OG003	3=Quite a Bit	-Participant is asked about specific well-being in the past 7 days

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	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX	1	20	8	20	20	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Myocardial infarction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Cardiac arrest	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected20 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Lung infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected20 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment		EG0003 affected20 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Ventricular fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0002 affected20 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0005 affected20 at risk
Mucositis oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Rectal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment		EG0004 affected20 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Activated partial thromboplastin time prolonged	Investigations	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Aspartate aminotransferase	Investigations	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Cardiac troponin I increased	Investigations	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Cardiac troponin T increased	Investigations	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment		EG0003 affected20 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment		EG0005 affected20 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment		EG0003 affected20 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment		EG0002 affected20 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment		EG0003 affected20 at risk
Leg pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Generalized muscle weakness	General disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	Tingling in fingers	EG0001 affected20 at risk
Cold sensitivity	Nervous system disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment		EG0006 affected20 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment		EG0002 affected20 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment		EG0002 affected20 at risk
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Bottom of feet felt sun burnt	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hand-foot skin reaction	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Cellulitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment		EG0001 affected20 at risk

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D055585	Physical Phenomena
D056831	Coordination Complexes
D009930	Organic Chemicals
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Term
D011827	Radiation
D000077150	Oxaliplatin
D002955	Leucovorin
D005472	Fluorouracil