Trial Outcomes & Findings for Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer (NCT NCT00216086)
NCT ID: NCT00216086
Last Updated: 2016-06-06
Results Overview
· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer. Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
36 months
Results posted on
2016-06-06
Participant Flow
Participant milestones
| Measure |
Single Group Assignment
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Single Group Assignment
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Diagnosis of Metastatic Disease
|
1
|
|
Overall Study
Social Reasons
|
2
|
Baseline Characteristics
Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
Single Group Assignment
n=22 Participants
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
7 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
15 participants
n=5 Participants
|
|
Tumor Node Metastatis (TNM) Stage
T2
|
1 participants
n=5 Participants
|
|
Tumor Node Metastatis (TNM) Stage
T3
|
19 participants
n=5 Participants
|
|
Tumor Node Metastatis (TNM) Stage
T4
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 months· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer. Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients.
Outcome measures
| Measure |
Single Group Assignment
n=18 Participants
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Pathological Complete Response (pCR) Rate
pCR
|
33 percentage of patients
Interval 13.0 to 59.0
|
|
Pathological Complete Response (pCR) Rate
pNCR
|
56 percentage of patients
Interval 31.0 to 78.0
|
SECONDARY outcome
Timeframe: 36 monthsTo determine the rates of local and distant disease recurrence after treatment.
Outcome measures
| Measure |
Single Group Assignment
n=18 Participants
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Local and Distant Disease Recurrence Rates
metastatic disease recurrence
|
22 percentage of particpants
|
|
Local and Distant Disease Recurrence Rates
locally recurrence
|
0 percentage of particpants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Data for this secondary objective was not captured or analyzed due to the withdrawal of funding and subsequent termination of the study.
To determine the rate of clinical response following induction chemotherapy with capecitabine and irinotecan, and also the overall clinical response after the completion of chemoradiation with capecitabine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsThe three year rate of Disease-Free Survival
Outcome measures
| Measure |
Single Group Assignment
n=18 Participants
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Disease-Free Survival
|
75.5 percentage
Interval 39.7 to 91.8
|
Adverse Events
Single Group Assignment
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Group Assignment
n=22 participants at risk
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
4.5%
1/22 • Number of events 1
|
|
Blood and lymphatic system disorders
EDEMA: HEAD AND NECK
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
HYPOTENSION
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
Single Group Assignment
n=22 participants at risk
Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Capecitabine: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
Irinotecan: Irinotecan 200 mg/m2 IV, day 1
EUS: biopsy per EUS
Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4
Surgery: Surgery within 8 weeks following chemoradiotherapy
Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion
|
|---|---|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
ANOREXIA
|
40.9%
9/22 • Number of events 13
|
|
Psychiatric disorders
APNEA
|
4.5%
1/22 • Number of events 1
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
4.5%
1/22 • Number of events 1
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
4.5%
1/22 • Number of events 1
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
31.8%
7/22 • Number of events 7
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.2%
4/22 • Number of events 4
|
|
Gastrointestinal disorders
DEHYDRATION
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHEA
|
81.8%
18/22 • Number of events 32
|
|
Nervous system disorders
DIZZINESS
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
18.2%
4/22 • Number of events 7
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
4.5%
1/22 • Number of events 1
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
77.3%
17/22 • Number of events 25
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
FLATULENCE
|
13.6%
3/22 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
13.6%
3/22 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
59.1%
13/22 • Number of events 14
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
27.3%
6/22 • Number of events 6
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
13.6%
3/22 • Number of events 3
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
18.2%
4/22 • Number of events 4
|
|
Cardiac disorders
HYPOTENSION
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
13.6%
3/22 • Number of events 3
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / PENIS
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / VAGINA
|
4.5%
1/22 • Number of events 1
|
|
General disorders
INSOMNIA
|
40.9%
9/22 • Number of events 10
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
18.2%
4/22 • Number of events 4
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
27.3%
6/22 • Number of events 6
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ANUS
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
9.1%
2/22 • Number of events 2
|
|
General disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / PHARYNX
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / RECTUM
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
72.7%
16/22 • Number of events 22
|
|
Nervous system disorders
NEUROLOGY - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
18.2%
4/22 • Number of events 4
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
18.2%
4/22 • Number of events 5
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
18.2%
4/22 • Number of events 4
|
|
Gastrointestinal disorders
PAIN / ANUS
|
4.5%
1/22 • Number of events 1
|
|
General disorders
PAIN / BACK
|
4.5%
1/22 • Number of events 1
|
|
General disorders
PAIN / BUTTOCK
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
9.1%
2/22 • Number of events 2
|
|
General disorders
PAIN / HEAD/HEADACHE
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
31.8%
7/22 • Number of events 8
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
4.5%
1/22 • Number of events 1
|
|
Reproductive system and breast disorders
PAIN / VAGINA
|
4.5%
1/22 • Number of events 1
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
22.7%
5/22 • Number of events 5
|
|
Blood and lymphatic system disorders
PLATELETS
|
9.1%
2/22 • Number of events 2
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
18.2%
4/22 • Number of events 4
|
|
Gastrointestinal disorders
PROCTITIS
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
PULMONARY HYPERTENSION
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / CHEMORADIATION
|
18.2%
4/22 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / RADIATION
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
13.6%
3/22 • Number of events 3
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 2
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
|
9.1%
2/22 • Number of events 2
|
|
General disorders
SWEATING (DIAPHORESIS)
|
9.1%
2/22 • Number of events 2
|
|
General disorders
SYNDROMES - OTHER (SPECIFY, __)
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
18.2%
4/22 • Number of events 4
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
31.8%
7/22 • Number of events 9
|
|
General disorders
WEIGHT LOSS
|
13.6%
3/22 • Number of events 3
|
Additional Information
Principal Investigator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place