Trial Outcomes & Findings for Pre-operative Adaptive Short Court Radiation Therapy in Gastric Cancer (NCT NCT04162665)
NCT ID: NCT04162665
Last Updated: 2025-01-09
Results Overview
pCR: no pathological signs of cancer
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
At the time of surgery (approximately 4.5 months)
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-operative Adaptive Short Court Radiation Therapy in Gastric Cancer
Baseline characteristics by cohort
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Age, Continuous
|
73.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 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
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of surgery (approximately 4.5 months)Population: 2 participants did not have surgery due to poor functional status and were not evaluable for this outcome measure.
pCR: no pathological signs of cancer
Outcome measures
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=2 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Complete Pathologic Response (pCR - Primary and Nodal) Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: At 1 year post radiationLocal control calculated from start of radiation.
Outcome measures
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Number of Participants With Local Control
|
4 Participants
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SECONDARY outcome
Timeframe: From baseline through 12 months after surgery/definitive end of treatment (estimated to be 16.5 months)Outcome measures
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Febrile neutropenia
|
2 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Anemia
|
2 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
GI bleed
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Gastric obstruction
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Failure to thrive
|
2 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Cholecystitis
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Lung infection
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Urinary tract infection
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Blood bilirubin increased
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Lymphocyte count decreased
|
2 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Neutrophil count decreased
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
White blood cell decreased
|
2 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Dehydration
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Hypoalbuminemia
|
2 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Syncope
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Delirium
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Pre-renal azotemia
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Acute kidney injury
|
1 Participants
|
|
Number of Grade 3 or Greater Toxicity as Defined by CTCAE Version 5.0
Percutaneous endoscopic gastromy tube clogging
|
1 Participants
|
SECONDARY outcome
Timeframe: At 1 year post radiation-Overall survival from start of radiation.
Outcome measures
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Overall Survival
|
4 Participants
|
SECONDARY outcome
Timeframe: At 1 year post radiation-Disease free means no locoregional and distant recurrence
Outcome measures
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Number of Participants With Disease-free Survival
|
4 Participants
|
SECONDARY outcome
Timeframe: Through completion of neoadjuvant chemotherapy (estimated to be 4.5 months)Outcome measures
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 Participants
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Number of Patients Able to Complete a Full Course of Total Neoadjuvant Chemotherapy
|
3 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Completion of radiation therapy (up to 2 weeks)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Completion of radiation therapy (up to 2 weeks)Outcome measures
Outcome data not reported
Adverse Events
Pre-operative Adaptive Short Course Radiation Therapy
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 participants at risk
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
GI bleed
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Gastric obstruction
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25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Renal and urinary disorders
Pre-renal azotemia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
Other adverse events
| Measure |
Pre-operative Adaptive Short Course Radiation Therapy
n=4 participants at risk
Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
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Blood and lymphatic system disorders
Cytopenia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
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Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Constipation
|
100.0%
4/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Mouth sores
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
4/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
General disorders
Cold sensitivity
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
General disorders
Decreased appetite
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
General disorders
Failure to thrive
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
General disorders
Fatigue
|
100.0%
4/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Hepatobiliary disorders
Cholecystitis
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Infections and infestations
COVID-19 infection
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
2/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Lymphocyte count decreased
|
100.0%
4/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Pancytopenia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Platelet count decreased
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
Vitamin D deficiency
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Investigations
White blood cell decreased
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Electrolyte abnormality
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Hypovolemic hyponatremia
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Metabolism and nutrition disorders
Malnutrition
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Nervous system disorders
Dizziness
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Nervous system disorders
Encephalopathy
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
50.0%
2/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Nervous system disorders
Syncope
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Psychiatric disorders
Altered mental status
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Psychiatric disorders
Delirium
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
75.0%
3/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Surgical and medical procedures
Percutaneous endoscopic gastromy tube clogging
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Adverse events and all-cause mortality was to be collected from baseline up to 12 months after surgery (or, for patients who do not undergo surgery, up to 12 months after definitive end of treatment).
|
Additional Information
Hyun Kim, M.D.
Washington University School of Medicine
Phone: 314-362-8502
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place