GTX-RT in Borderline Resectable Pancreatic Cancer
|Pancreatic Cancer||Drug: Capecitabine Drug: Gemcitabine Drug: Docetaxel Radiation: Stereotactic body radiation therapy (SBRT) Other: Restaging review after radiation Procedure: Surgery Drug: 5-Fluorouracil||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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: Up to 3 years ]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.
- Progression-Free Survival (PFS) at Three Years [ Time Frame: 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.
- Overall Survival (OS) Rate [ Time Frame: 12 months ]OS at time of analysis, calculated from date of enrollment to date of death from any cause.
|Study Start Date:||February 2013|
|Study Completion Date:||October 2014|
|Primary Completion Date:||September 2014 (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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754623
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Ravi Shridhar, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|