Trial Outcomes & Findings for Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer (NCT NCT00593866)
NCT ID: NCT00593866
Last Updated: 2015-09-11
Results Overview
The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
13 weeks post radiation
Results posted on
2015-09-11
Participant Flow
Participant milestones
| Measure |
Radiation Dose Escalation With Gemcitabine
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Radiation Dose Escalation With Gemcitabine
n=50 Participants
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Tumor Location
Head
|
33 participants
n=5 Participants
|
|
Tumor Location
Neck
|
10 participants
n=5 Participants
|
|
Tumor Location
Body/Tail
|
7 participants
n=5 Participants
|
|
Tumor Size
|
3.25 centimeters (cm)
n=5 Participants
|
|
Tumor Volume
|
47.9 Cubic Centimeter (cc)
n=5 Participants
|
|
Baseline CA 19-9
|
102 Units Per Millilitre (U/mL)
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 weeks post radiationThe maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.
Outcome measures
| Measure |
Radiation Dose Escalation With Gemcitabine
n=50 Participants
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
|---|---|
|
The Maximum Tolerated Radiation Dose
|
55 Gray (Gy)
|
SECONDARY outcome
Timeframe: 2 YearsOutcome measures
| Measure |
Radiation Dose Escalation With Gemcitabine
n=50 Participants
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
|---|---|
|
The Percentage of Participants Free From Local Progression at 2 Years
|
59 percentage of participants
Interval 32.0 to 79.0
|
Adverse Events
Radiation Dose Escalation With Gemcitabine
Serious events: 34 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation Dose Escalation With Gemcitabine
n=50 participants at risk
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.0%
3/50 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
16.0%
8/50 • Number of events 19
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.0%
11/50 • Number of events 26
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
14.0%
7/50 • Number of events 18
|
|
Blood and lymphatic system disorders
Platelets
|
4.0%
2/50 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Fatigue
|
6.0%
3/50 • Number of events 3
|
|
General disorders
Fever
|
12.0%
6/50 • Number of events 6
|
|
General disorders
Rigors/chills
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Weight loss
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.0%
4/50 • Number of events 5
|
|
Gastrointestinal disorders
Obstruction, GI, Stomach
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Ulcer, GI, Duodenum
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2
|
|
Vascular disorders
Hemorrhage, GI, Abdomen NOS
|
6.0%
3/50 • Number of events 4
|
|
Vascular disorders
Hemorrhage, GI, Duodenum
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hemorrhage, GI, Varices
|
2.0%
1/50 • Number of events 2
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
8.0%
4/50 • Number of events 5
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils, Abdomen
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophil, Blood
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils, Duodenum
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils, Lung
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection, Duodenum
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection, Skin
|
4.0%
2/50 • Number of events 2
|
|
Infections and infestations
Infection, Urinary Tract
|
2.0%
1/50 • Number of events 2
|
|
Infections and infestations
Infection, Blood
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Edema: limb
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
6.0%
3/50 • Number of events 3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
8.0%
4/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Confusion
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Neurology - Other
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Pain, Abdomen
|
4.0%
2/50 • Number of events 2
|
|
Cardiac disorders
Pain, Chest
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, Extremity-limb
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Pain, Penis
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.0%
1/50 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.0%
2/50 • Number of events 2
|
Other adverse events
| Measure |
Radiation Dose Escalation With Gemcitabine
n=50 participants at risk
INTENSITY MODULATED RADIOTHERAPY
Radiation dose escalation:
Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
* BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level
Gemcitabine:
1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
6/50 • Number of events 15
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
44.0%
22/50 • Number of events 44
|
|
Blood and lymphatic system disorders
Lymphopenia
|
48.0%
24/50 • Number of events 43
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
46.0%
23/50 • Number of events 45
|
|
Blood and lymphatic system disorders
Platelets
|
12.0%
6/50 • Number of events 9
|
|
General disorders
Fatigue
|
8.0%
4/50 • Number of events 5
|
|
General disorders
Fever
|
12.0%
6/50 • Number of events 6
|
|
Gastrointestinal disorders
Anorexia
|
8.0%
4/50 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
12.0%
6/50 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
5/50 • Number of events 5
|
|
Vascular disorders
Hemorrhage, GI
|
8.0%
4/50 • Number of events 5
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas
|
12.0%
6/50 • Number of events 9
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
10.0%
5/50 • Number of events 6
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
10.0%
5/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
16.0%
8/50 • Number of events 11
|
|
Gastrointestinal disorders
Pain, Abdomen
|
8.0%
4/50 • Number of events 5
|
Additional Information
Dr. Mark Zalupski
University of Michigan Comprehensive Cancer Center
Phone: 734-615-3969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place