GTX-RT in Borderline Resectable Pancreatic Cancer
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.
Radiation: stereotactic body radiation therapy (SBRT)
Other: restaging review after radiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)|
- Margin-negative (R0) Resection Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]The primary endpoint is correlation of a radiosensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response); R1 (Moderate Response); R2 (Minimal Response); R3 (No Response).
- Overall Survival (OS) Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]OS will be calculated from date of enrollment to date of death from any cause. Investigators will also compare OS between resected and non-resected patients. Comparative analysis will be performed by Kaplan-Meier analysis and 2-sided log-rank test.
- Progression-Free Survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Progression-Free Survival (PFS) PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Investigators will also compare PFS between resected and non-resected patients. Comparative analysis will be performed by Kaplan-Meier analysis and 2-sided log-rank test.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: 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.
Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.
Other Name: Xeloda®Drug: gemcitabine
On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.
Other Name: Gemzar®Drug: docetaxel
On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.
Other Name: Taxotere®Radiation: stereotactic body radiation therapy (SBRT)
30/40 Gy to pancreatic tumor/area of borderline resectability
Other Name: SBRTOther: restaging review after radiation
After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.Procedure: surgery
Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.Drug: 5-Fluorouracil
Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).
Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment pancreatic tumor tissues will be collected and immediately frozen at the time of staging endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens and run on microarray analysis to determine radiosensitivity index score. Borderline resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT. They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754623
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Helen Jump 813-745-4834 email@example.com|
|Principal Investigator: Ravi Shridhar, M.D., Ph.D.|
|Sub-Investigator: Gregory Springett, M.D., Ph.D.|
|Sub-Investigator: Sarah Hoffe, M.D.|
|Sub-Investigator: Pamela Hodul, M.D.|
|Sub-Investigator: Jason Klapman, M.D.|
|Sub-Investigator: Shivakumar Vignesh, M.D.|
|Sub-Investigator: Amit Mahipal, M.D.|
|Principal Investigator:||Ravi Shridhar, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|