Trial Outcomes & Findings for Perioperative Therapy for Resectable Pancreatic Cancer (NCT NCT00609336)
NCT ID: NCT00609336
Last Updated: 2017-07-13
Results Overview
Time at which Kaplan-Meier estimate of overall survival drops below 50%
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
5 years
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Surgery
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV
|
|---|---|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
LA or Met at Surgery
|
9
|
Baseline Characteristics
Perioperative Therapy for Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All eligible patients
Time at which Kaplan-Meier estimate of overall survival drops below 50%
Outcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
|
31.6 months
Interval 14.2 to 58.1
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: all eligible patients
Kaplan-Meier estimate of overall survival at 5 years
Outcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Percent of Patients Surviving at 5 Years
|
31.6 percentage of eligible pts alive
|
SECONDARY outcome
Timeframe: From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 yearsPopulation: Among eligible patients who received surgery
The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
Outcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=22 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Median Recurrence Free Survival Following Pancreaticoduodenectomy
|
31.3 months
Interval 12.5 to
Upper limit is infinite.
|
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: Clinical response not collected.
Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: all eligible patients with non-missing data
The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90
Outcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=22 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after surgeryPopulation: Biomarker data not collected.
Biochemical response is a decrease of \>= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 weeks following the completion of chemoradiotherapyPopulation: all eligible patients
Outcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Surgical Completion Rate and Complication Rate
Completion rate
|
22 Participants
|
|
Surgical Completion Rate and Complication Rate
Complication rate
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after surgery (the end of adjuvant chemotherapy)Population: All eligible patients
Outcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Any Grade 2 CTCAE toxicity
|
21 occurrence of toxicities
|
|
Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Any Grade 3 CTCAE toxicity
|
121 occurrence of toxicities
|
|
Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Any Grade 4 CTCAE toxicity
|
14 occurrence of toxicities
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 Participants
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Percent of Patients Surviving at Annual Intervals
Year 1
|
81 percentage of participants
|
|
Percent of Patients Surviving at Annual Intervals
Year 2
|
62 percentage of participants
|
|
Percent of Patients Surviving at Annual Intervals
Year 3
|
45 percentage of participants
|
|
Percent of Patients Surviving at Annual Intervals
Year 4
|
37 percentage of participants
|
|
Percent of Patients Surviving at Annual Intervals
Year 5
|
31 percentage of participants
|
Adverse Events
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Serious events: 32 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 participants at risk；n=35 participants at risk
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.1%
6/35 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
5/35 • Number of events 5
|
|
Investigations
Elevated Bilirubin
|
11.4%
4/35 • Number of events 4
|
|
Blood and lymphatic system disorders
Fever, Neutropenic
|
8.6%
3/35 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-foot Syndrome
|
57.1%
20/35 • Number of events 22
|
|
Infections and infestations
Infection
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
8.6%
3/35 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
68.6%
24/35 • Number of events 31
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
10/35 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Anasarca
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Bacterial Sepsis
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis With Stent Occlusion
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystic Abcess
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Entero Cutaneous Fistula
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Fatigue
|
11.4%
4/35 • Number of events 4
|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoatremic
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • Number of events 2
|
|
Hepatobiliary disorders
Intrahepatic Absesses
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Lower GI Bleed
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
2.9%
1/35 • Number of events 2
|
|
Hepatobiliary disorders
Non-Malignant Ascitess
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleeds
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Obstructive Jaundice
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Odynophagia
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Shoulder Pain
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Transient Ischemic Attacks
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Transaminitis
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
n=32 participants at risk；n=35 participants at risk
See Detailed Description
gemcitabine hydrochloride: Given IV
docetaxel: Given IV
capecitabine: Given PO
intensity-modulated radiation therapy: Undergo IMRT
oxaliplatin: Given IV
pancreatic surgical procedure: Undergo pancreaticoduodenectomy
therapeutic conventional surgery: Undergo therapeutic conventional surgery
gemcitabine: Given IV
oxaliplatin: Given IV
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
21.9%
7/32 • Number of events 8
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.4%
3/32 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Elevated Bilirubin
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infection
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Maculopapular Rash
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - Upper Torso
|
3.1%
1/32 • Number of events 1
|
|
Hepatobiliary disorders
Transaminase
|
3.1%
1/32 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place