Trial Outcomes & Findings for Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer (NCT NCT00456599)
NCT ID: NCT00456599
Last Updated: 2015-12-03
Results Overview
The percent of patients alive and disease-free at two years.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
two years
Results posted on
2015-12-03
Participant Flow
Participant milestones
| Measure |
Gemcitabine and Oxaliplatin With Radiation Therapy
Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
Completed Cycle 1
|
66
|
|
Overall Study
Initiated Cycle 2
|
61
|
|
Overall Study
Completed Protocol Surgery
|
48
|
|
Overall Study
Completed Resection
|
43
|
|
Overall Study
Post-Surgery Adjuvent Therapy
|
26
|
|
Overall Study
Completed 4th Cycle of Chemotherapy
|
24
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Gemcitabine and Oxaliplatin With Radiation Therapy
Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
|
|---|---|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin & Gemcitabine With Radiation
n=68 Participants
Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy).
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two yearsPopulation: 43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.
The percent of patients alive and disease-free at two years.
Outcome measures
| Measure |
Oxaliplatin & Gemcitabine With Radiation
n=41 Participants
Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy).
|
|---|---|
|
Two-year Disease Free Survival.
|
26.1 percentage of patients
Interval 16.1 to 37.4
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.
Median time for disease recurrence after surgery.
Outcome measures
| Measure |
Oxaliplatin & Gemcitabine With Radiation
n=41 Participants
Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy).
|
|---|---|
|
Time to Treatment Failure
|
10.4 months
Interval 2.3 to 35.8
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression).
Percent overall survival was calculated for all evaluable patients.
Outcome measures
| Measure |
Oxaliplatin & Gemcitabine With Radiation
n=68 Participants
Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy).
|
|---|---|
|
Overall Survival
|
18.2 months
Interval 13.0 to 26.9
|
Adverse Events
Oxaliplatin & Gemcitabine With Radiation
Serious events: 28 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin & Gemcitabine With Radiation
n=71 participants at risk
Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
3/71 • Number of events 3 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
3/71 • Number of events 3 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Alkaline phosphatase increased
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Anorexia
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
2/71 • Number of events 2 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Cardiac disorders
Cardiac disorder
|
2.8%
2/71 • Number of events 2 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Cardiac disorders
Chest pain
|
2.8%
2/71 • Number of events 2 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Creatine phosphokinase increased
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
General disorders
Death
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
4/71 • Number of events 4 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
General disorders
Edema limbs
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Enteritis
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
General disorders
Fatigue
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
General disorders
Fever
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
GI - Other (Specify)
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
General disorders
General symptom
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatobiliary - Other (Specify)
|
1.4%
1/71 • Number of events 2 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Hyperbilirubinemia
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Infections and infestations
Infection, Biliary tree
|
1.4%
1/71 • Number of events 3 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Leukocytes
|
7.0%
5/71 • Number of events 8 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Leukopenia
|
5.6%
4/71 • Number of events 8 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Vascular disorders
Lymph leakage
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Lymphopenia
|
7.0%
5/71 • Number of events 7 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • Number of events 4 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
8.5%
6/71 • Number of events 10 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Neutrophils
|
2.8%
2/71 • Number of events 4 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Infections and infestations
Opportunisitic infection
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
4.2%
3/71 • Number of events 5 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Platelets
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Vascular disorders
Thrombosis
|
1.4%
1/71 • Number of events 1 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • Number of events 3 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
Other adverse events
| Measure |
Oxaliplatin & Gemcitabine With Radiation
n=71 participants at risk
Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray \[Gy\] fractions (total dose, 30 Gy).
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
4/71 • Number of events 6 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
11.3%
8/71 • Number of events 10 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
General disorders
Fatigue
|
21.1%
15/71 • Number of events 29 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
21.1%
15/71 • Number of events 59 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
7.0%
5/71 • Number of events 6 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Hyperbilirubinemia
|
8.5%
6/71 • Number of events 12 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
4/71 • Number of events 6 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.9%
12/71 • Number of events 23 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.0%
5/71 • Number of events 6 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
4/71 • Number of events 4 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Blood and lymphatic system disorders
Leukocytes
|
36.6%
26/71 • Number of events 59 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Leukopenia
|
12.7%
9/71 • Number of events 10 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Lymphopenia
|
22.5%
16/71 • Number of events 26 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
21.1%
15/71 • Number of events 20 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
12.7%
9/71 • Number of events 13 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Neutrophils
|
31.0%
22/71 • Number of events 53 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.0%
5/71 • Number of events 5 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
18.3%
13/71 • Number of events 17 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Investigations
Platelets
|
40.8%
29/71 • Number of events 70 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Nervous system disorders
Taste alteration
|
8.5%
6/71 • Number of events 6 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
8/71 • Number of events 10 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
|
Metabolism and nutrition disorders
Weight loss
|
8.5%
6/71 • Number of events 8 • Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place