A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02873598|
Recruitment Status : Active, not recruiting
First Posted : August 19, 2016
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: FOLFIRINOX or gemcitabine/abraxane Radiation: SBRT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer|
|Actual Study Start Date :||November 17, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: FOLFIRINOX or gemcitabine/abraxane followed by SBRT
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane
Drug: FOLFIRINOX or gemcitabine/abraxane
Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.
Other Name: nab-paclitaxel
After completion of induction chemotherapy, stereotactic body radiation therapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions.
- The maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in locally advanced pancreatic cancer (LAPC) patients who have not developed distant progression after induction chemotherapies. [ Time Frame: Up to 3 months ]This will be accomplished by the standard 3+3 dose escalation design. Dose limiting toxicities (DLT) are defined by ≥ Grade 3 treatment-related GI toxicity within 3 months of SBRT. These include: (1) Bowel (includes bowel perforation, obstruction, or hemorrhage) and (2) Stomach (bleeding ulcer, perforation) as determined by imaging or endoscopic evaluation.
- Local Control [ Time Frame: Up to 5 years ]Local control (LC) will be measured from completion of SBRT to the time of identification of any local progression by imaging or surgical exploration. The pattern of patients experiencing local, distant or local with distant failure will be estimated using competing risks method.
- Progression Free Survival [ Time Frame: Up to 5 years ]Progression free survival (PFS) will be measured from completion of SBRT to the time of tumor progression or death due to any cause. PFS will be estimated using the method of Kaplan and Meier.
- Overall Survival [ Time Frame: Up to 5 years ]Overall survival (OS) will be measured from completion of SBRT until death due to any cause. OS will be estimated using the method of Kaplan and Meier.
- Small Intestine Changes [ Time Frame: 6 weeks after SBRT ]Investigators will measure changes in the perfusion/permeability related parameters of peripancreatic small intestine before, during and after SBRT for patients using pCT and correlating these changes with the development of gastrointestinal toxicity such as duodenal ulcers, strictures, or enteritis. Patients will undergo baseline, post-first-fraction SBRT and post-treatment CT scans.
- Vascular and Cellular Changes [ Time Frame: 6 weeks after SBRT ]Investigators will measure changes in diffusion and perfusion/permeability by using perfusion CT derived parameters that can predict treatment response and to assess any correlation between these perfusion CT derived parameters and local control and progression-free survival
- Quality of Life (QOL) [ Time Frame: 6 months after SBRT ]The primary objective of the QOL study is to document the patient's experience of treatment for locally advanced pancreatic cancer by examining global QOL, physical symptoms, physical functioning and emotional well-being at baseline, during treatment, and after treatment. QOL measures including EORTC-QLQ-C30 questionnaire and the Pancreatic Cancer subscale (EORTC-PAN26) will be assessed 14 days prior to SBRT (Time 0), 10-12 weeks after SBRT (Time 1), and 6 months after SBRT (Time 2). The primary QOL endpoints include the EORTC global QOL, physical symptoms, physical functioning and emotional well-being.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873598
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Sana Karam, MD||University of Colorado, Denver|