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Trial record 94 of 1612 for:    Pancreatic Cancer | United States

GTX-RT in Borderline Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01754623
Recruitment Status : Terminated (Lack of pre-treatment tissue to make the study plan feasible.)
First Posted : December 21, 2012
Results First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Capecitabine
Drug: Gemcitabine
Drug: Docetaxel
Radiation: Stereotactic body radiation therapy (SBRT)
Other: Restaging review after radiation
Procedure: Surgery
Drug: 5-Fluorouracil
Enrollment 9
Recruitment Details Participants were enrolled at Moffitt Cancer Center from March 2013 through December 2013.
Pre-assignment Details  
Arm/Group Title Chemotherapy Followed by Radiation Treatment
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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.

Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Chemotherapy Followed by Radiation Treatment
Hide Arm/Group Description

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 Number of Baseline Participants 9
Hide Baseline Analysis Population Description
All participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  22.2%
>=65 years
7
  77.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Margin-negative (R0) Resection Rate
Hide Description 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.
Time Frame Up to 3 years
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Hide Analysis Population Description
All participants with resection
Arm/Group Title Chemotherapy Followed by Radiation Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of participants
67
2.Secondary Outcome
Title Progression-Free Survival (PFS) at Three Years
Hide Description 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.
Time Frame 3 years
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Hide Analysis Population Description
Evaluable participants at 3 years.
Arm/Group Title Chemotherapy Followed by Radiation Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (OS) Rate
Hide Description OS at time of analysis, calculated from date of enrollment to date of death from any cause.
Time Frame 12 months
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Hide Analysis Population Description
All participants per group
Arm/Group Title All Participants -Chemotherapy Followed by Radiation Treatment Resection Group -Chemotherapy Followed by Radiation Treatment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 9 3
Measure Type: Number
Unit of Measure: percentage of participants
33 100
Time Frame 1 year, 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy Followed by Radiation Treatment
Hide Arm/Group Description

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.

All-Cause Mortality
Chemotherapy Followed by Radiation Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy Followed by Radiation Treatment
Affected / at Risk (%) # Events
Total   4/9 (44.44%)    
Gastrointestinal disorders   
Abdominal pain  1  1/9 (11.11%)  1
Diarrhea  1  2/9 (22.22%)  2
Mucositis oral  1  1/9 (11.11%)  1
Hepatobiliary disorders   
Bile duct stenosis  1  1/9 (11.11%)  1
Hepatobiliary disorders - Other, Liver abscess  1  1/9 (11.11%)  1
Infections and infestations   
Biliary tract infection  1  1/9 (11.11%)  1
Urinary tract infection  1  1/9 (11.11%)  1
Investigations   
Alanine aminotransferase increased  1  1/9 (11.11%)  1
Aspartate aminotransferase increased  1  1/9 (11.11%)  1
Blood bilirubin increased  1  1/9 (11.11%)  1
Neutrophil count decreased  1  1/9 (11.11%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/9 (22.22%)  2
Hyponatremia  1  1/9 (11.11%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/9 (11.11%)  1
Vascular disorders   
Hypotension  1  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chemotherapy Followed by Radiation Treatment
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  6/9 (66.67%)  14
Gastrointestinal disorders   
Diarhea  1  6/9 (66.67%)  9
Constipation  1  5/9 (55.56%)  6
Abdmonimal pain  1  2/9 (22.22%)  4
Mucositis oral  1  2/9 (22.22%)  3
Vomiting  1  2/9 (22.22%)  2
Abdominal distension  1  1/9 (11.11%)  1
Bloating  1  1/9 (11.11%)  1
Dyspepsia  1  1/9 (11.11%)  1
Nausea  1  1/9 (11.11%)  2
General disorders   
Fatigue  1  9/9 (100.00%)  13
Fever  1  2/9 (22.22%)  2
Flu like symptoms  1  2/9 (22.22%)  2
Chills  1  1/9 (11.11%)  1
Edema limbs  1  1/9 (11.11%)  2
Irritability  1  1/9 (11.11%)  1
Infections and infestations   
Lip infection  1  1/9 (11.11%)  1
Lung infection  1  1/9 (11.11%)  1
Sepsis  1  1/9 (11.11%)  1
Urinary tract infection  1  1/9 (11.11%)  1
Investigations   
Neutrophil count decreased  1  3/9 (33.33%)  5
Platelet count decreased  1  3/9 (33.33%)  8
Aspartate aminotransferase increased  1  1/9 (11.11%)  2
Weight loss  1  2/9 (22.22%)  2
White blood cell decreased  1  2/9 (22.22%)  5
Blood bilirubin increased  1  1/9 (11.11%)  2
CD4 lymphocytes decreased  1  1/9 (11.11%)  4
Lipase increased  1  1/9 (11.11%)  1
Lymphocyte count decreased  1  1/9 (11.11%)  1
Pancreatic enzymes  1  1/9 (11.11%)  1
Metabolism and nutrition disorders   
Anorexia  1  4/9 (44.44%)  5
Dehydration  1  3/9 (33.33%)  4
Hyperglycemia  1  4/9 (44.44%)  7
Hypoalbuminemia  1  3/9 (33.33%)  8
Hypokalemia  1  3/9 (33.33%)  3
Hyponatremia  1  2/9 (22.22%)  4
Hypocalcemia  1  1/9 (11.11%)  2
Hypomagnesemia  1  1/9 (11.11%)  1
Hypophosphatemia  1  1/9 (11.11%)  2
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/9 (11.11%)  1
Nervous system disorders   
Dizziness  1  2/9 (22.22%)  2
Dysgeusia  1  1/9 (11.11%)  1
Headache  1  1/9 (11.11%)  1
Psychiatric disorders   
Confusion  1  2/9 (22.22%)  2
Depressioin  1  2/9 (22.22%)  2
Insomnia  1  2/9 (22.22%)  2
Hallucinations  1  1/9 (11.11%)  1
Restlessness  1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/9 (11.11%)  1
Epistaxis  1  1/9 (11.11%)  1
Hiccups  1  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  3/9 (33.33%)  6
Alopecia  1  2/9 (22.22%)  3
Palmar-plantar erthrodysesthesia syndrome  1  2/9 (22.22%)  3
Pruritus  1  2/9 (22.22%)  2
Rash acneiform  1  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders - Other, Tegaderm skin reaction from IV  1  1/9 (11.11%)  1
Vascular disorders   
Superficial thrombophlebitis  1  3/9 (33.33%)  4
Hypertension  1  2/9 (22.22%)  2
Hypotension  1  2/9 (22.22%)  2
Hematoma  1  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The study only accrued 9 (of planned 35) participants. It was not possible to collect adequate pre-treatment tissue for radiosensitivity index (RSI) analysis, pre-treatment. The study was terminated before planned completion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ravi Shridhar, M.D., Ph.D.
Organization: Florida Hospital Orlando (Formerly at Moffitt Cancer Center)
Phone: 407-303-5857
EMail: ravi.shridhar.md@flhosp.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01754623     History of Changes
Other Study ID Numbers: MCC-16932
First Submitted: December 18, 2012
First Posted: December 21, 2012
Results First Submitted: June 17, 2015
Results First Posted: August 13, 2015
Last Update Posted: August 13, 2015