Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
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|ClinicalTrials.gov Identifier: NCT00833859|
Recruitment Status : Terminated (Abandoned - Lack of funding after only 2 patients enrolled)
First Posted : February 2, 2009
Results First Posted : May 26, 2011
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Drug: GTX (gemcitabine, docetaxel and capecitabine) Radiation: stereotactic body radiation therapy||Phase 2|
Cycle 1 and 2:
- Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m^2 intravenous piggy back (IVPB) over 30 min
- Days 4, 11 and 25, 32 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 1-14 and 22-35 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
Cycle 3 and 4:
- Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min
- Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Chemotherapy followed by Radiation Treatment
GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)
Drug: GTX (gemcitabine, docetaxel and capecitabine)
GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
Radiation: stereotactic body radiation therapy
stereotactic body radiation therapy (SBRT) 25
Other Name: SBRT
- Number of Participants With Resectability [ Time Frame: 6 months per patient ]The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: 6 months per patient ]Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.
- Number of Participants With Objective Response [ Time Frame: 6 months per patient ]Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.
- Number of Participants With Overall Survival [ Time Frame: 6 months per patient ]We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833859
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Gregory Springett, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|