Trial Outcomes & Findings for GTX-RT in Borderline Resectable Pancreatic Cancer (NCT NCT01754623)
NCT ID: NCT01754623
Last Updated: 2015-08-13
Results Overview
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-08-13
Participant Flow
Participants were enrolled at Moffitt Cancer Center from March 2013 through December 2013.
Participant milestones
| Measure |
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GTX-RT in Borderline Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Chemotherapy Followed by Radiation Treatment
n=9 Participants
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All participants with resection
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
Outcome measures
| Measure |
Chemotherapy Followed by Radiation Treatment
n=3 Participants
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
Resection Group -Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
|---|---|---|
|
Margin-negative (R0) Resection Rate
|
67 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Evaluable participants at 3 years.
PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants per group
OS at time of analysis, calculated from date of enrollment to date of death from any cause.
Outcome measures
| Measure |
Chemotherapy Followed by Radiation Treatment
n=9 Participants
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
Resection Group -Chemotherapy Followed by Radiation Treatment
n=3 Participants
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
|---|---|---|
|
Overall Survival (OS) Rate
|
33 percentage of participants
|
100 percentage of participants
|
Adverse Events
Chemotherapy Followed by Radiation Treatment
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy Followed by Radiation Treatment
n=9 participants at risk
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, Liver abscess
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Infections and infestations
Biliary tract infection
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
Other adverse events
| Measure |
Chemotherapy Followed by Radiation Treatment
n=9 participants at risk
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
|
|---|---|
|
Gastrointestinal disorders
Diarhea
|
66.7%
6/9 • Number of events 9 • 1 year, 5 months
|
|
Gastrointestinal disorders
Constipation
|
55.6%
5/9 • Number of events 6 • 1 year, 5 months
|
|
Gastrointestinal disorders
Abdmonimal pain
|
22.2%
2/9 • Number of events 4 • 1 year, 5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
22.2%
2/9 • Number of events 3 • 1 year, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Gastrointestinal disorders
Bloating
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 2 • 1 year, 5 months
|
|
General disorders
Fatigue
|
100.0%
9/9 • Number of events 13 • 1 year, 5 months
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
General disorders
Flu like symptoms
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Number of events 2 • 1 year, 5 months
|
|
General disorders
Irritability
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
44.4%
4/9 • Number of events 5 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
3/9 • Number of events 4 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.4%
4/9 • Number of events 7 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
3/9 • Number of events 8 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
3/9 • Number of events 3 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Number of events 4 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 2 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 2 • 1 year, 5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
3/9 • Number of events 6 • 1 year, 5 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
2/9 • Number of events 3 • 1 year, 5 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erthrodysesthesia syndrome
|
22.2%
2/9 • Number of events 3 • 1 year, 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Tegaderm skin reaction from IV
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
6/9 • Number of events 14 • 1 year, 5 months
|
|
Investigations
Neutrophil count decreased
|
33.3%
3/9 • Number of events 5 • 1 year, 5 months
|
|
Investigations
Platelet count decreased
|
33.3%
3/9 • Number of events 8 • 1 year, 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 2 • 1 year, 5 months
|
|
Investigations
Weight loss
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Investigations
White blood cell decreased
|
22.2%
2/9 • Number of events 5 • 1 year, 5 months
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 2 • 1 year, 5 months
|
|
Investigations
CD4 lymphocytes decreased
|
11.1%
1/9 • Number of events 4 • 1 year, 5 months
|
|
Investigations
Lipase increased
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Investigations
Pancreatic enzymes
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Psychiatric disorders
Confusion
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Psychiatric disorders
Depressioin
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Psychiatric disorders
Hallucinations
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Psychiatric disorders
Restlessness
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Vascular disorders
Superficial thrombophlebitis
|
33.3%
3/9 • Number of events 4 • 1 year, 5 months
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Vascular disorders
Hypotension
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Vascular disorders
Hematoma
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • 1 year, 5 months
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Infections and infestations
Lip infection
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Infections and infestations
Lung infection
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 1 • 1 year, 5 months
|
Additional Information
Ravi Shridhar, M.D., Ph.D.
Florida Hospital Orlando (Formerly at Moffitt Cancer Center)
Phone: 407-303-5857
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place