Trial Outcomes & Findings for Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer (NCT NCT00354679)
NCT ID: NCT00354679
Last Updated: 2016-05-16
Results Overview
All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
2 years
Results posted on
2016-05-16
Participant Flow
Participant milestones
| Measure |
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
|
|---|---|
|
Overall Study
Patient Not Treated
|
1
|
Baseline Characteristics
Irinotecan, Cisplatin, Bevacizumab, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
n=34 Participants
Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAll toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.
Outcome measures
| Measure |
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
n=33 Participants
Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
|
|---|---|
|
Evaluation of Safety and Toxicity
Anorexia
|
1 participants
|
|
Evaluation of Safety and Toxicity
Atrial flutter
|
1 participants
|
|
Evaluation of Safety and Toxicity
CNS cerebrovascular ischemia
|
1 participants
|
|
Evaluation of Safety and Toxicity
Death not associated with CTCAE term- Death NOS
|
1 participants
|
|
Evaluation of Safety and Toxicity
Dehydration
|
5 participants
|
|
Evaluation of Safety and Toxicity
Esophagitis
|
7 participants
|
|
Evaluation of Safety and Toxicity
Febrile neutropenia
|
3 participants
|
|
Evaluation of Safety and Toxicity
Hemoglobin
|
1 participants
|
|
Evaluation of Safety and Toxicity
Hemorrhage, CNS
|
1 participants
|
|
Evaluation of Safety and Toxicity
Infection, other
|
2 participants
|
|
Evaluation of Safety and Toxicity
Leukocytes (total WBC)
|
2 participants
|
|
Evaluation of Safety and Toxicity
Nausea
|
2 participants
|
|
Evaluation of Safety and Toxicity
Neutrophils/granulocytes (ANC/AGC)
|
1 participants
|
|
Evaluation of Safety and Toxicity
Pain - Chest wall
|
1 participants
|
|
Evaluation of Safety and Toxicity
Pain - Extremity-limb
|
1 participants
|
|
Evaluation of Safety and Toxicity
Perforation, GI- Jejunum
|
1 participants
|
|
Evaluation of Safety and Toxicity
Phosphate, low (hypophosphatemia)
|
1 participants
|
|
Evaluation of Safety and Toxicity
Platelets
|
1 participants
|
|
Evaluation of Safety and Toxicity
Potassium, low (hypokalemia)
|
2 participants
|
|
Evaluation of Safety and Toxicity
Thrombosis/embolism (vascular access-related)
|
1 participants
|
|
Evaluation of Safety and Toxicity
Thrombosis/thrombus/embolism
|
4 participants
|
|
Evaluation of Safety and Toxicity
Vomiting
|
2 participants
|
Adverse Events
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
Serious events: 16 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
n=33 participants at risk
Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
|
|---|---|
|
General disorders
Death not associated with CTCAE term- Death NOS
|
3.0%
1/33
|
|
Gastrointestinal disorders
Dehydration
|
15.2%
5/33
|
|
Gastrointestinal disorders
Esophagitis
|
21.2%
7/33
|
|
General disorders
Febrile neutropenia
|
9.1%
3/33
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.0%
1/33
|
|
Nervous system disorders
Hemorrhage, CNS
|
3.0%
1/33
|
|
Infections and infestations
Infection, other
|
6.1%
2/33
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
6.1%
2/33
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
3.0%
1/33
|
|
General disorders
Pain - Chest wall
|
3.0%
1/33
|
|
General disorders
Pain - Extremity-limb
|
3.0%
1/33
|
|
Gastrointestinal disorders
Perforation, GI- Jejunum
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Platelets
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
3.0%
1/33
|
|
Cardiac disorders
Thrombosis/embolism (vascular access-related)
|
3.0%
1/33
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
12.1%
4/33
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33
|
|
General disorders
Anorexia
|
3.0%
1/33
|
|
Cardiac disorders
Atrial flutter
|
3.0%
1/33
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
3.0%
1/33
|
|
Cardiac disorders
Ischemia cerebrovascular
|
3.0%
1/33
|
Other adverse events
| Measure |
Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger
n=33 participants at risk
Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
21.2%
7/33
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
9.1%
3/33
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
27.3%
9/33
|
|
Blood and lymphatic system disorders
AST, SGOT
|
21.2%
7/33
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
24.2%
8/33
|
|
Gastrointestinal disorders
Constipation
|
12.1%
4/33
|
|
Metabolism and nutrition disorders
Creatinine
|
6.1%
2/33
|
|
Gastrointestinal disorders
Dehydration
|
6.1%
2/33
|
|
Gastrointestinal disorders
Diarrhea
|
15.2%
5/33
|
|
General disorders
Dysphagia (Difficulty swallowing)
|
6.1%
2/33
|
|
Gastrointestinal disorders
Esophagitis
|
18.2%
6/33
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
27.3%
9/33
|
|
General disorders
Febrile neutropenia
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
63.6%
21/33
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
12.1%
4/33
|
|
General disorders
Hair loss/alopecia (scalp or body)
|
21.2%
7/33
|
|
Blood and lymphatic system disorders
Hemoglobin
|
84.8%
28/33
|
|
Blood and lymphatic system disorders
Prothrombin time international normalized ratio
|
18.2%
6/33
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
78.8%
26/33
|
|
Blood and lymphatic system disorders
Lymphopenia
|
93.9%
31/33
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
6.1%
2/33
|
|
Gastrointestinal disorders
Nausea
|
15.2%
5/33
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
66.7%
22/33
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
69.7%
23/33
|
|
Blood and lymphatic system disorders
Platelets
|
24.2%
8/33
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
15.2%
5/33
|
|
Blood and lymphatic system disorders
Partial thromboplastin time
|
15.2%
5/33
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Trglycrde, high (hypertriglyceridemia)
|
6.1%
2/33
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
5/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place