Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

Brief summary public domain (ClinicalTrials.gov)

This multi-institutional trial aims to evaluate the potential benefit and side effects of adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after chemotherapy with gemcitabine for locally advanced pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

Treatment on this protocol requires placement of 3-5 gold (99.9% pure, 1-5 mm length, or visicoils) fiducials for targeting purposes. The fiducials will be used as surrogates for targeting the daily tumor position during treatment. The fiducials will be placed directly into the tumor and/or periphery under endoscopic ultrasound or CT guidance. Gemcitabine prior to SBRT is optional. If given, up to 3 weeks in a 6-week period is allowable, and may be given prior to study enrollment. Administration should be on a 3-week on, 1-week off schedule, weekly at 1,000 mg/m2. Simulation should be done 5 days or more following placement of fiducials. For simulation patients will be positioned supine in an Alpha Cradle or equivalent immobilization device will be custom made for each patient. Standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT will be obtained on each patient The 4D-CT scan will be used for characterizing target motion during quiet respiration. Following simulation, patients may be treated either in a respiratory gated (Trilogy, Elekta, Novalis) or a respiratory tracking (Cyberknife) manner. The selection of which radiotherapy treatment machine to use is left to each investigator. All patients will receive 5 fractions of 6.6 Gy delivered over a five-day period. Ideally all 5 fractions should be delivered Monday through Friday, however it may be delivered over 2 weeks as long as the patient receives at least 2 fractions a week. Gemcitabine, cycles should resume up to 4 weeks following SBRT on a 3-week on, 1-week off schedule, administered weekly at 1,000 mg/m2.A detailed medical history with physical examination and quality of life assessment will be performed at 4 months, 6 months, 9 months and 1 year. A follow-up visit at 4 weeks is optional and may be done by patient's Medical Oncologist. Scans may be done at 4-6 week visit if patient is being re-evaluated for resection. In years 2-5 the follow up interval will be every 3-6 months, as determined by the investigator at each participating institution. Follow up intervals may also be more frequent as indicated clinically. A complete blood count (CBC), comprehensive chemistry panel, tumor marker studies, and quality of life assessment will be performed at each follow-up interval until death. As permitted by each participating institution, separate samples of blood will be drawn and retained for research efforts to develop novel serum biomarkers.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year. [One year.]. Number, Number of toxicities.. SBRT and Gemzar (n=49): 5.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment. [Within 3 months of treatment.]. Number, Number of toxicities.. SBRT and Gemzar (n=49): 14.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up . [Up to 5 years of follow up.]. Median, Months (95% Confidence Interval). SBRT and Gemzar (n=49): 7.8 (5.8 to 10.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up. [Up to 5 years of follow up.]. Median, Months (95% Confidence Interval). SBRT and Gemzar (n=49): 13.9 (10.2 to 16.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up. [Up to 5 years of follow up.]. Number, Proportion of participants with FFLP (95% Confidence Interval). SBRT and Gemzar (n=49): 0.78 (0.60 to 0.89).