Trial Outcomes & Findings for S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer (NCT NCT00686166)
NCT ID: NCT00686166
Last Updated: 2018-05-18
Results Overview
Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
15-20 weeks from registration
Results posted on
2018-05-18
Participant Flow
Participant milestones
| Measure |
Chemo + Chemo and Radiation + Surgery
Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
Eligible
|
78
|
|
Overall Study
Eligible and Began Protocol Therapy
|
74
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Chemo + Chemo and Radiation + Surgery
Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progression/Relapse
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Not Protocol Specified
|
1
|
|
Overall Study
Ineligible
|
5
|
|
Overall Study
Did not begin protocol therapy
|
4
|
Baseline Characteristics
S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer
Baseline characteristics by cohort
| Measure |
Chemo + Chemo and Radiation + Surgery
n=74 Participants
Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection
|
|---|---|
|
Age, Continuous
|
56.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15-20 weeks from registrationPopulation: Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.
Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.
Outcome measures
| Measure |
Chemo + Chemo and Radiation + Surgery
n=72 Participants
Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection
|
Chemotherapy + Radiation
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
|
Tumor Resection
Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
|
|---|---|---|---|
|
Pathologic Complete Response Rate
|
25 percentage of participants
Interval 16.0 to 37.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Eligible and analyzable patients
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Outcome measures
| Measure |
Chemo + Chemo and Radiation + Surgery
n=74 Participants
Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection
|
Chemotherapy + Radiation
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
|
Tumor Resection
Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
|
|---|---|---|---|
|
3-year Disease-free Survival
|
68 percentage of participants
Interval 57.0 to 78.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
Only adverse events that are possibly, probably or definitely related to study regimen are reported.
Outcome measures
| Measure |
Chemo + Chemo and Radiation + Surgery
n=74 Participants
Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection
|
Chemotherapy + Radiation
n=68 Participants
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
|
Tumor Resection
n=63 Participants
Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
|
|---|---|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pruritus/itching
|
15 Participants
|
5 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Weight gain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
ALT, SGPT (serum glutamic pyruvic transaminase)
|
15 Participants
|
11 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
AST, SGOT
|
15 Participants
|
12 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Acidosis (metabolic or respiratory)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Adult respiratory distress syndrome (ARDS)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Albumin, serum-low (hypoalbuminemia)
|
11 Participants
|
10 Participants
|
7 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Alkaline phosphatase
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Allergic reaction/hypersensitivity
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Allergic rhinitis
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Amylase
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Anorexia
|
20 Participants
|
18 Participants
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Bicarbonate, serum-low
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Bilirubin (hyperbilirubinemia)
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Blood/Bone Marrow-Other
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Bone: spine-scoliosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Burn
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Calcium, serum-low (hypocalcemia)
|
8 Participants
|
13 Participants
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Coagulation-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Colitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Confusion
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Constipation
|
34 Participants
|
24 Participants
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Constitutional Symptoms-Other
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Cough
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Creatinine
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Cystitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Cytokine release syndrome/acute infusion reaction
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dehydration
|
8 Participants
|
11 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dermatology/Skin-Other
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Diarrhea
|
34 Participants
|
48 Participants
|
10 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Distention/bloating, abdominal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dizziness
|
10 Participants
|
7 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dry mouth/salivary gland (xerostomia)
|
7 Participants
|
6 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dry skin
|
20 Participants
|
16 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dysphagia (difficulty swallowing)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Dyspnea (shortness of breath)
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Edema: limb
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Enteritis (inflammation of the small bowel)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Extrapyramidal/involuntary movement/restlessness
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Fatigue (asthenia, lethargy, malaise)
|
48 Participants
|
41 Participants
|
22 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Flatulence
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Flu-like syndrome
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Flushing
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Gastritis (including bile reflux gastritis)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Gastrointestinal-Other
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Glucose, serum-high (hyperglycemia)
|
13 Participants
|
12 Participants
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hair loss/Alopecia (scalp or body)
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Heartburn/dyspepsia
|
13 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hemoglobin
|
13 Participants
|
19 Participants
|
21 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hemolysis
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hemorrhage, GI - Rectum
|
9 Participants
|
6 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hemorrhage/Bleeding-Other
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hemorrhage/bleeding w/surgery, intra- or post-op
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hemorrhoids
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hepatobiliary/Pancreas-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hiccoughs (hiccups, singultus)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hot flashes/flushes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hyperpigmentation
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hypertension
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Hypotension
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
INR (of prothrombin time)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Ileus, GI (functional obstruction of bowel)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Neutrophils/granulocytes (ANC/AGC)
|
4 Participants
|
9 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Incontinence, anal
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Incontinence, urinary
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Infection with unknown ANC - Abdomen NOS
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Infection with unknown ANC - Anal/perianal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Infection with unknown ANC - Sinus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Infection with unknown ANC - Urinary tract NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Infection-Other
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Injection site reaction/extravasation changes
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Insomnia
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Irregular menses (change from baseline)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Leak (including anastomotic), GU - Stoma
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Leukocytes (total WBC)
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Lipase
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Lymphatics-Other
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Lymphopenia
|
4 Participants
|
13 Participants
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Magnesium, serum-high (hypermagnesemia)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Magnesium, serum-low (hypomagnesemia)
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Metabolic/Laboratory-Other
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mood alteration - agitation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mood alteration - anxiety
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mood alteration - depression
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mucositis/stomatitis (clinical exam) - Anus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mucositis/stomatitis (clinical exam) - Oral cavity
|
14 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mucositis/stomatitis (functional/symp) - Anus
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mucositis/stomatitis (functional/symp) - Oral cav
|
9 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Mucositis/stomatitis (functional/symp) - Rectum
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Muscle weakness, not d/t neuropathy - Extrem-lower
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Muscle weakness, not d/t neuropathy - Extrem-upper
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Muscle weakness, not d/t neuropathy - body/general
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Musculoskeletal/Soft Tissue-Other
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Nail changes
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Nasal cavity/paranasal sinus reactions
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Nausea
|
37 Participants
|
25 Participants
|
7 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Neurology-Other
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Neuropathy: motor
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Neuropathy: sensory
|
38 Participants
|
34 Participants
|
17 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Obstruction, GI - Rectum
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Obstruction, GI - Small bowel NOS
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Ocular/Visual-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
PTT (Partial thromboplastin time)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Abdomen NOS
|
8 Participants
|
19 Participants
|
7 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Anus
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Back
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Bone
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Chest/thorax NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Esophagus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Extremity-limb
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Face
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Head/headache
|
10 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Joint
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Kidney
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Muscle
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Oral cavity
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Pelvis
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Perineum
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Rectum
|
5 Participants
|
20 Participants
|
17 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Urethra
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain - Vagina
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pain-Other
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Phlebitis (including superficial thrombosis)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Phosphate, serum-low (hypophosphatemia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Photosensitivity
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Platelets
|
9 Participants
|
13 Participants
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pleural effusion (non-malignant)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Potassium, serum-high (hyperkalemia)
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Potassium, serum-low (hypokalemia)
|
14 Participants
|
14 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Proctitis
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pulmonary hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Pulmonary/Upper Respiratory-Other
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rash/desquamation
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rash: acne/acneiform
|
64 Participants
|
42 Participants
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rash: dermatitis associated w/Chemoradiation
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rash: dermatitis associated w/radiation
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rash: erythema multiforme
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rash: hand-foot skin reaction
|
12 Participants
|
12 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Renal failure
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Renal/Genitourinary-Other
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Rigors/chills
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
SVT and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
SVT and nodal arrhythmia - Atrial tachycardia/PAT
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
SVT and nodal arrhythmia - Sinus tachycardia
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Sexual/Reproductive Function-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Sodium, serum-high (hypernatremia)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Sodium, serum-low (hyponatremia)
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Somnolence/depressed level of consciousness
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Sweating (diaphoresis)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Syncope (fainting)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Taste alteration (dysgeusia)
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Thrombosis/embolism (vascular access-related)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Thrombosis/thrombus/embolism
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Tinnitus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Tremor
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Urinary frequency/urgency
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Urinary retention (including neurogenic bladder)
|
0 Participants
|
2 Participants
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Vascular-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Ventricular arrhythmia - Ventricular tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Vision-blurred vision
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Vomiting
|
13 Participants
|
5 Participants
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Weight loss
|
11 Participants
|
15 Participants
|
12 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Wound complication, non-infectious
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Chemotherapy
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
Chemotherapy + Radiation
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Tumor Resection
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy
n=74 participants at risk
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m\^2 IV (Day 1), cetuximab 250 mg/m\^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
|
Chemotherapy + Radiation
n=68 participants at risk
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
|
Tumor Resection
n=63 participants at risk
Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
|
|---|---|---|---|
|
General disorders
Death - Multi-organ failure
|
1.4%
1/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
1.4%
1/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
1.4%
1/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
Other adverse events
| Measure |
Chemotherapy
n=74 participants at risk
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m\^2 IV (Day 1), cetuximab 250 mg/m\^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
|
Chemotherapy + Radiation
n=68 participants at risk
Patients receive oxaliplatin 50 mg/m\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
|
Tumor Resection
n=63 participants at risk
Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
17.6%
13/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
27.9%
19/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
33.3%
21/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Constipation
|
45.9%
34/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
35.3%
24/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.9%
5/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Diarrhea
|
45.9%
34/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
70.6%
48/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
15.9%
10/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
9.5%
7/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
2.7%
2/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
17.6%
13/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
12.2%
9/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.8%
3/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Incontinence, anal
|
1.4%
1/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
18.9%
14/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
12.2%
9/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
2.9%
2/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Rectum
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
37/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
36.8%
25/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
11.1%
7/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
10.8%
8/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
27.9%
19/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
11.1%
7/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Pain - Anus
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Pain - Rectum
|
6.8%
5/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
29.4%
20/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
27.0%
17/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
13/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
6.3%
4/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
64.9%
48/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
60.3%
41/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
34.9%
22/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/Chemoradiation
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
10.3%
7/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated w/radiation
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
20.3%
15/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
16.2%
11/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.8%
3/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
AST, SGOT
|
20.3%
15/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
17.6%
12/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Alkaline phosphatase
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.8%
3/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
6.8%
5/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.4%
3/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Creatinine
|
2.7%
2/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
6.3%
4/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Leukocytes (total WBC)
|
2.7%
2/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.8%
3/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Lymphopenia
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
19.1%
13/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
14.3%
9/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Metabolic/Laboratory-Other
|
4.1%
3/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
13.2%
9/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Platelets
|
12.2%
9/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
19.1%
13/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
9.5%
6/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Weight loss
|
14.9%
11/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
22.1%
15/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
19.0%
12/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
14.9%
11/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
14.7%
10/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
11.1%
7/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.0%
20/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
26.5%
18/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
14.3%
9/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
10.8%
8/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
19.1%
13/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
14.3%
9/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.8%
8/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
16.2%
11/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
17.6%
13/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
17.6%
12/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
9.5%
6/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
4.1%
3/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
18.9%
14/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
20.6%
14/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
6.3%
4/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
9.5%
7/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
9.5%
6/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
4.1%
3/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.5%
1/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
4.1%
3/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
6.8%
5/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
2.9%
2/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Nervous system disorders
Dizziness
|
13.5%
10/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
10.3%
7/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Nervous system disorders
Neuropathy: sensory
|
51.4%
38/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
50.0%
34/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
27.0%
17/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Nervous system disorders
Pain - Head/headache
|
13.5%
10/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.4%
3/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
4.1%
3/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Psychiatric disorders
Insomnia
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
8.1%
6/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.4%
3/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Psychiatric disorders
Mood alteration - depression
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
2.9%
2/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
2.9%
2/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
9.5%
6/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
8.8%
6/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.8%
5/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
5.9%
4/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
27.0%
20/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
23.5%
16/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
3.2%
2/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.4%
3/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
1.6%
1/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
20.3%
15/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.5%
7/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
7.4%
5/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
4.8%
3/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
86.5%
64/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
61.8%
42/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
14.3%
9/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
16.2%
12/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
17.6%
12/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
6.3%
4/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Vascular disorders
Hypotension
|
5.4%
4/74 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
2.9%
2/68 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
0.00%
0/63 • Up to 4 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
Additional Information
SWOG Statistician
SWOG Statistical Center
Phone: 206-667-4408
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place