Clinical trial NCT01754623
Conditions: Pancreatic Cancer
Keywords: Pancreas Pancreatic Neoplasms Stereotactic Radiosurgery Borderline Resectable Gastrointestinal Gemcitabine Capecitabine Fluorouracil Docetaxel SBRT GTX Chemotherapy
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2013-02-01; Completion date: 2014-10-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: 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.
Interventions: intervention 1: Capecitabine intervention 2: Gemcitabine intervention 3: Docetaxel intervention 4: Stereotactic body radiation therapy (SBRT) intervention 5: Restaging review after radiation intervention 6: Surgery intervention 7: 5-Fluorouracil
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 30/40 Gy to pancreatic tumor/area of borderline resectability intervention 5: 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. intervention 6: Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response. intervention 7: Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).

Protocol documents: