Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma
|ClinicalTrials.gov Identifier: NCT01360593|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2011
Last Update Posted : June 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Capecitabine Radiation: Stereotactic Body Radiation Therapy (SBRT)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma A Prospective Evaluation in Patients With Locally Advanced Pancreas Cancer|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
|Gem, Xeloda, SBRT||
Gemcitabine will be administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.
Other Name: Gemzar
Capecitabine will be taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.
Other Name: Xeloda
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Fractionated SBRT will be delivered to patients that have stable disease, partial response, or complete response after chemo in the following manner:
12 Gy x 3 fractions (36 Gy total) This will be given every other day.
- Local progression-free survival (LPFS) achieved in subjects with locally-advanced, potentially resectable pancreatic adenocarcinoma treated with SBRT and gemcitabine/capecitabine chemotherapy [ Time Frame: 24 months ]In this study, LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. Death or development of distant disease is not regarded as an event. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
- Objective response rate, time to progression (TTP) and overall survival (OS) [ Time Frame: 24 months ]TTP is defined as the time from enrollment to disease progression. Disease progression will be defined as PD in the target volume, or development of distant disease. OS is defined as the length of time from enrollment to confirmed death from any cause.
- Number of patients that are able to undergo a margin-negative resection after neoadjuvant therapy [ Time Frame: 24 months ]All patients that undergo attempted surgical evaluation will have their pathology records reviewed and discussed with the operating surgeon to determine margin status. Margins will be classified as negative, close (1-2.5mm), microscopically positive, and grossly positive.
- QOL of subjects treated with SBRT for unresectable locally-advanced pancreatic adenocarcinoma [ Time Frame: 24 months ]QOL evaluation will be administered prior to SBRT, after completion of SBRT, and at each follow-up. The survey will be the FACT-G
- Measure acute and late toxicities associated with SBRT for locally advanced pancreas cancer [ Time Frame: 24 months ]All patients will be monitored for potential treatment-related toxicity throughout treatment as detailed in the schema. Toxicity will be graded according to the CTCAE v4. Acute toxicity is defined as toxicity occurring within 3 months of completion of SBRT. Late toxicity is defined as toxicity occurring greater than 3 months after treatment.
- Role of FDG-PET/CT in the setting of pancreatic cancer [ Time Frame: 24 months ]Ideally, all follow-up FDG-PET/CT scans after chemo will be performed on the same scanner to help limit variability in the SUVs detected by different scanners. For those patients with non-FDG avid tumors, their response to therapy will be assessed by CT scan. The most recent consensus recommendations by the NCI on assessing PET response indicate semi-quantitative SUV (standard uptake value) analysis based on lean body mass and/or body surface area be used in determining 18F-FDG uptake. We will use the EORTC 1999 criteria for defining 18F-FDG response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360593
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Dwight E Heron, MD||UPMC Shadyside|
|Principal Investigator:||Rodney Wegner, MD||UPMC Shadyside|