Trial Outcomes & Findings for Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer (NCT NCT00557492)
NCT ID: NCT00557492
Last Updated: 2018-09-25
Results Overview
Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Up to 48 months
Results posted on
2018-09-25
Participant Flow
Participant milestones
| Measure |
FDR GEM + BEV +/- BEV/RT
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
58
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
FDR GEM + BEV +/- BEV/RT
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Overall Study
Change in health insurance
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1
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Baseline Characteristics
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer
Baseline characteristics by cohort
| Measure |
FDR GEM + BEV +/- BEV/RT
n=59 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Age, Continuous
|
60 years
n=5 Participants
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Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
30 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Participants who underwent laparoscopy and pancreatic resection.
Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=43 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Rate of Margin Negative Surgical Resection (R0 Resection Rate)
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88 percentage of participants
Interval 75.0 to 96.0
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PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: Participants who underwent laparoscopy and pancreatic resections.
Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=43 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Rate of Pathologic Complete Response (pCR)
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2.3 percentage of participants
Interval 0.1 to 12.0
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Includes entire study cohort.
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=58 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Overall Survival (OS)
|
16.8 months
Interval 14.9 to 21.3
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Includes participants who underwent laparoscopy and pancreatic resection.
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=43 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Overall Survival (OS)
|
19.7 months
Interval 16.5 to 28.2
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Includes entire study cohort.
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=58 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Progression-free Survival (PFS)
|
6.6 months
Interval 4.9 to 12.4
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SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: Includes participants who underwent laparoscopy and pancreatic resection.
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=43 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Progression-free Survival (PFS)
|
12.9 months
Interval 7.0 to 18.7
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SECONDARY outcome
Timeframe: Up to 48 monthsNumber of participants that underwent resection / per the total number of evaluable participants
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=58 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Rate of Surgical Resection
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74 percentage of participants
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SECONDARY outcome
Timeframe: Up to 48 monthsCT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=58 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Radiographic Tumor Response
metastatic progression (at restaging)
|
4 Participants
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Radiographic Tumor Response
stable disease
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39 Participants
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Radiographic Tumor Response
partial response
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5 Participants
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Radiographic Tumor Response
progressive disease
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10 Participants
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SECONDARY outcome
Timeframe: Baseline and up to 48 monthsPopulation: Participants that did NOT demonstrate metastatic progression upon restaging CT.
Percentage decrease in Ca 19-9 level (in serum)
Outcome measures
| Measure |
FDR GEM + BEV +/- BEV/RT
n=54 Participants
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Ca 19-9 Level (in Serum) - Biomarker Response
|
25 percentage decrease in serum Ca19-9 leve
Standard Deviation 80
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Adverse Events
FDR GEM + BEV +/- BEV/RT
Serious events: 10 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FDR GEM + BEV +/- BEV/RT
n=59 participants at risk
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Skin and subcutaneous tissue disorders
Wound complication, non-infectious
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1.7%
1/59
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Gastrointestinal disorders
Dehydration
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1.7%
1/59
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Gastrointestinal disorders
Leak (including anastomotic), GI, Pancreas
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1.7%
1/59
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Gastrointestinal disorders
Nausea
|
1.7%
1/59
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Gastrointestinal disorders
Obstruction, GI, Small bowel NOS
|
1.7%
1/59
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|
Blood and lymphatic system disorders
Hemorrhage/Bleeding
|
1.7%
1/59
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas
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1.7%
1/59
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|
Infections and infestations
Infection
|
1.7%
1/59
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|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS
|
3.4%
2/59
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General disorders
Pain, Abdomen NOS
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1.7%
1/59
|
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Vascular disorders
Thrombosis/thrombus/embolism
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5.1%
3/59
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Other adverse events
| Measure |
FDR GEM + BEV +/- BEV/RT
n=59 participants at risk
Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m\^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1-2 cm vascular margin, +/- laparoscopy and resection after day 85.
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|---|---|
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Blood and lymphatic system disorders
Leukocytes (total WBC)
|
8.5%
5/59
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Blood and lymphatic system disorders
Platelets
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11.9%
7/59
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
13.6%
8/59
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|
Blood and lymphatic system disorders
Hemoglobin
|
15.3%
9/59
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|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
35.6%
21/59
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Skin and subcutaneous tissue disorders
Dermatology/Skin
|
6.8%
4/59
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|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
10.2%
6/59
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|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.2%
6/59
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.2%
6/59
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
10.2%
6/59
|
|
Gastrointestinal disorders
Gastrointestinal
|
10.2%
6/59
|
|
Gastrointestinal disorders
Anorexia
|
11.9%
7/59
|
|
Gastrointestinal disorders
Constipation
|
11.9%
7/59
|
|
Gastrointestinal disorders
Diarrhea
|
16.9%
10/59
|
|
Gastrointestinal disorders
Vomiting
|
16.9%
10/59
|
|
Gastrointestinal disorders
Nausea
|
35.6%
21/59
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
8.5%
5/59
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
11.9%
7/59
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|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
13.6%
8/59
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
15.3%
9/59
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|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
15.3%
9/59
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|
Metabolism and nutrition disorders
Alkaline phosphatase
|
18.6%
11/59
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|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
22.0%
13/59
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
27.1%
16/59
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
37.3%
22/59
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|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue
|
6.8%
4/59
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|
Nervous system disorders
Mood alteration, Anxiety
|
10.2%
6/59
|
|
General disorders
Pain
|
8.5%
5/59
|
|
General disorders
Pain, Head/headache
|
10.2%
6/59
|
|
General disorders
Pain, Abdomen NOS
|
20.3%
12/59
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
6.8%
4/59
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place