A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer

Memorial Sloan Kettering Cancer Center7 sites in 1 country11 target enrollmentDecember 2015

ConditionsPancreatic Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 11
Locations: 7
Primary Endpoint: maximum tolerated dose (MTD) of SBRT
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out the maximum dose of SBRT that can be safely given after chemotherapy for treatment of pancreatic cancer that cannot be removed surgically.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

December 16, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytopathologically confirmed adenocarcinoma of the pancreas.
•Locally advanced, unresectable pancreatic cancer as confirmed by the multidisciplinary input from a hepatobiliary surgeon and as defined on CT as having tumor abutment of \>180° (\> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement.
•No evidence of distant metastasis either prior to or after induction chemotherapy.
•Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks.
•Pancreatic tumor size ≤ 5 cm.
•Age ≥18 years
•Patients must have acceptable organ and marrow function as defined below:
•Leukocytes \>3,000/uL
•Absolute neutrophil count \>1,500/uL
•Platelets \>50,000/uL

Exclusion Criteria

•Patients who have had prior abdominal radiotherapy.
•Patients receiving any other investigational agents
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Contraindication to Magnetic Resonance Imaging
•Patients in which iodine contrast is contraindicated
•Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.

Outcomes

Primary Outcomes

maximum tolerated dose (MTD) of SBRT

Time Frame: after at least 3 months of induction chemortherapy

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). We will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3.