Trial Outcomes & Findings for S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct (NCT NCT00789958)
NCT ID: NCT00789958
Last Updated: 2018-04-09
Results Overview
Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Up to 2 years from registration
Results posted on
2018-04-09
Participant Flow
Participant milestones
| Measure |
Adjuvant Chemotherapy + Chemoradiotherapy
Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
Eligible and Analyzable
|
79
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Adjuvant Chemotherapy + Chemoradiotherapy
Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Progression
|
3
|
|
Overall Study
not protocol specified
|
1
|
|
Overall Study
Not eligible/not analyzable
|
26
|
Baseline Characteristics
S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct
Baseline characteristics by cohort
| Measure |
Adjuvant Chemotherapy + Chemoradiotherapy
n=79 Participants
Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Margin of Resection
Negative (R0)
|
54 participants
n=5 Participants
|
|
Margin of Resection
Microscopically positive (R1)
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years from registrationPopulation: Eligible and analyzable patients that received protocol treatment.
Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=54 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
n=25 Participants
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
Stratum-specific (R0 and R1) 2-year Overall Survival
|
67 percentage of participants
Interval 52.0 to 78.0
|
60 percentage of participants
Interval 38.0 to 76.0
|
SECONDARY outcome
Timeframe: Up to 5 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 drug are reported.
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=79 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Skin Infection w/normal ANC or Gr 1-2 neutrophils
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection-Other (Specify)
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
5 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
6 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac troponin I (cTnI)
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Constipation
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dehydration
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
6 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
4 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GI - Duodenum
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GI - Lower GI NOS
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lung Infection w/normal ANC or Gr 1-2 neutrophils
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
35 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Phosphate, serum-low (hypophosphatemia)
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
2 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
2 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rash: hand-foot skin reaction
|
10 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Syncope (fainting)
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/embolism (vascular access-related)
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ulcer, GI - Duodenum
|
1 Participants
|
—
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ventricular arrhythmia - Ventricular tachycardia
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from registrationPopulation: Eligible and analyzable patients that received protocol treatment.
Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=79 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
2-year Overall Survival for All Patients
|
65 percentage of participants
Interval 53.0 to 74.0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from registrationPopulation: Eligible and analyzable patients that received protocol treatment.
Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=54 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
n=25 Participants
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
2-year Stratum-specific Disease-free Survival
|
54 percentage of participants
Interval 40.0 to 66.0
|
48 percentage of participants
Interval 27.0 to 65.0
|
SECONDARY outcome
Timeframe: Up to 2 years from registrationPopulation: Eligible and analyzable patients that received protocol treatment.
Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=79 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
2-year Disease-free Survival in All Patients
|
52 percentage of participants
Interval 40.0 to 62.0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from registrationPopulation: Eligible and analyzable patients that received protocol treatment.
Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=54 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
n=25 Participants
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
2-year Stratum-specific Local Relapse Rate
|
9 percentage of participants
Interval 2.0 to 17.0
|
16 percentage of participants
Interval 2.0 to 30.0
|
SECONDARY outcome
Timeframe: Up to 2 years from registrationPopulation: Eligible and analyzable patients that received protocol treatment.
Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Outcome measures
| Measure |
Patients With Negative Margins of Resection (R0)
n=79 Participants
Eligible and analyzable patients that received a resection with negative (R0) margins.
|
Patients w/Microscopically Positive Margin of Resection (R1)
Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
|
|---|---|---|
|
2-year Overall Local Relapse Rate
|
11 percentage of participants
Interval 4.0 to 18.0
|
—
|
Adverse Events
Adjuvant Chemotherapy + Chemoradiotherapy
Serious events: 2 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adjuvant Chemotherapy + Chemoradiotherapy
n=79 participants at risk
Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
|
|---|---|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
|
1.3%
1/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Duodenum
|
1.3%
1/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Ulcer, GI - Duodenum
|
1.3%
1/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Thrombocytopenia
|
1.3%
1/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
Other adverse events
| Measure |
Adjuvant Chemotherapy + Chemoradiotherapy
n=79 participants at risk
Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
|
|---|---|
|
Blood and lymphatic system disorders
Low hemoglobin level
|
57.0%
45/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Constipation
|
30.4%
24/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Diarrhea
|
44.3%
35/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
10.1%
8/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
4/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
8.9%
7/79 • Up to 5 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
|
21.5%
17/79 • Up to 5 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
|
12.7%
10/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Nausea
|
62.0%
49/79 • Up to 5 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
|
30.4%
24/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
15/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
General disorders
Edema: limb
|
13.9%
11/79 • Up to 5 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)
|
81.0%
64/79 • Up to 5 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
|
21.5%
17/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
General disorders
Pain-Other
|
13.9%
11/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
General disorders
Rigors/chills
|
6.3%
5/79 • Up to 5 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)
|
26.6%
21/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
AST, SGOT
|
27.8%
22/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Alkaline phosphatase
|
26.6%
21/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
7.6%
6/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Leukocytes (total WBC)
|
53.2%
42/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Lymphopenia
|
26.6%
21/79 • Up to 5 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)
|
65.8%
52/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Investigations
Platelets
|
32.9%
26/79 • Up to 5 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)
|
12.7%
10/79 • Up to 5 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
|
21.5%
17/79 • Up to 5 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)
|
7.6%
6/79 • Up to 5 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)
|
31.6%
25/79 • Up to 5 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-high (hyperkalemia)
|
6.3%
5/79 • Up to 5 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)
|
10.1%
8/79 • Up to 5 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)
|
7.6%
6/79 • Up to 5 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
|
7.6%
6/79 • Up to 5 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
|
6.3%
5/79 • Up to 5 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 - Muscle
|
11.4%
9/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Nervous system disorders
Dizziness
|
11.4%
9/79 • Up to 5 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
|
30.4%
24/79 • Up to 5 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
|
15.2%
12/79 • Up to 5 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)
|
17.7%
14/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Psychiatric disorders
Insomnia
|
13.9%
11/79 • Up to 5 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
|
10.1%
8/79 • Up to 5 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
|
7.6%
6/79 • Up to 5 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
|
5.1%
4/79 • Up to 5 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
Allergic rhinitis
|
5.1%
4/79 • Up to 5 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
|
13.9%
11/79 • Up to 5 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)
|
6.3%
5/79 • Up to 5 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
|
11.4%
9/79 • Up to 5 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
|
8.9%
7/79 • Up to 5 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
|
5.1%
4/79 • Up to 5 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
|
16.5%
13/79 • Up to 5 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
|
34.2%
27/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Vascular disorders
Hypertension
|
6.3%
5/79 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
|
|
Vascular disorders
Hypotension
|
6.3%
5/79 • Up to 5 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
Phone: 206-667-4408
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place