Trial Outcomes & Findings for Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma (NCT NCT00737438)
NCT ID: NCT00737438
Last Updated: 2016-02-03
Results Overview
A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of \> or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of \< 35% on the week 3 PET scan compared with baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
2 years
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
All Patients
ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Patients
ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Patient ineligible
|
1
|
Baseline Characteristics
Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma
Baseline characteristics by cohort
| Measure |
All Patients
n=23 Participants
ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsA good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of \> or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of \< 35% on the week 3 PET scan compared with baseline.
Outcome measures
| Measure |
All Patients
n=20 Participants
ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
|
|---|---|
|
Overall Response Will be Characterized by the Patient's FDG-PET Scan
Metabolic Responder
|
11 participants
|
|
Overall Response Will be Characterized by the Patient's FDG-PET Scan
Non-Metabolic Responder
|
9 participants
|
Adverse Events
All Patients
Serious events: 12 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=23 participants at risk
ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
|
|---|---|
|
General disorders
Anorexia
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term- Death NOS
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Fistula, GI- Stomach
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3/4 neutropenia, Lung (pneumonia)
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Leak, GI- Small Bowel
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Leak, GI- Stomach
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Mucositis (Clincal exam)- Oral cavity
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
17.4%
4/23 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Pain - Abdomen NOS
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Thrombosis/embolism (vascular access-related)
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
3/23 • Number of events 3
|
|
General disorders
Weight loss
|
8.7%
2/23 • Number of events 2
|
Other adverse events
| Measure |
All Patients
n=23 participants at risk
ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
47.8%
11/23
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
8.7%
2/23
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
17.4%
4/23
|
|
General disorders
Anorexia
|
30.4%
7/23
|
|
Blood and lymphatic system disorders
AST, SGOT
|
17.4%
4/23
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
21.7%
5/23
|
|
Metabolism and nutrition disorders
Creatinine
|
17.4%
4/23
|
|
Gastrointestinal disorders
Dehydration
|
17.4%
4/23
|
|
Gastrointestinal disorders
Diarrhea
|
30.4%
7/23
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
56.5%
13/23
|
|
General disorders
Fever (in the absence of neutropenia)
|
13.0%
3/23
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
52.2%
12/23
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
8.7%
2/23
|
|
Blood and lymphatic system disorders
Hemoglobin
|
69.6%
16/23
|
|
Blood and lymphatic system disorders
prothrombin time international normalized ratio
|
8.7%
2/23
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
52.2%
12/23
|
|
Blood and lymphatic system disorders
Lymphopenia
|
34.8%
8/23
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
13.0%
3/23
|
|
General disorders
Mucositis - Larynx
|
8.7%
2/23
|
|
Gastrointestinal disorders
Nausea
|
26.1%
6/23
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
60.9%
14/23
|
|
General disorders
Pain - Abdomen NOS
|
21.7%
5/23
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
43.5%
10/23
|
|
Blood and lymphatic system disorders
Platelets
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
21.7%
5/23
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Sodium, high (hypernatremia)
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
13.0%
3/23
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place