Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region

Not Applicable

Completed

Brief Summary: This is a single center, single arm unblinded prospective study of the safety of pancreatic stereotactic body radiation therapy (SBRT) in patients with unresectable, borderline resectable, or recurrent pancreatic/periampullary cancers who have previously undergone treatment with chemotherapy, surgery, photodynamic therapy, conventionally fractionated radiation treatment, or any combination of these therapies.

Primary Objective

• To estimate rates of acute (within 3 months of treatment) grade 3 or greater gastrointestinal and hematologic toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers who have previously received other treatment.

Secondary Objectives

* To estimate rates of late (\> 3 months after treatment) grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal toxicity in patients treated with Linac-based SBRT for pancreatic or periampullary cancers

* To estimate rates of local progression, overall survival, metastasis-free survival, and progression-free survival in patients with pancreatic or periampullary cancers treated with fractionated Linac-based SBRT.

* To evaluate the ability of Linac-based SBRT to provide pain control in patients with pain related to a pancreatic or periampullary tumor.

* To evaluate quality of life in patients undergoing treatment with Linac-based SBRT for pancreatic or periampullary cancers.

Detailed Description: Patients will receive 5 fractions of 5 gray (Gy) or 6.6 Gy delivered over a five-day period based on whether or not they have received prior radiation therapy to the pancreatic region. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week. Initial patient positioning will be based on volumetric kV (cone-beam computerized tomography) imaging with shifts to bony anatomy as appropriate. Orthogonal kV/MV or kV/kV projection imaging will be used to verify the location of the fiducials prior to delivery of the first treatment beam. A secondary shift based on the location of fiducials may be utilized, as indicated by the position of the fiducials. For free-breathing treatments, kV fluoroscopic images should be obtained to confirm the anticipated position of these fiducials during the entire respiratory cycle. Active monitoring of treatment delivery accuracy will be accomplished using kV and/or MV projection imaging, either immediately before or during all (or a subset of) treatment fields. Patient-specific dosimetric quality assurance (QA) will be performed as per standard practice in the Department of Radiation Oncology, Indiana University School of Medicine.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation	Stereotactic Body Radiation	Patients will receive 5 fractions of 5 Gy or 6.6 Gy (dose depending upon whether or not they have received prior radiation therapy to the pancreatic region) delivered over a five-day period.

Primary Outcome Measures

Name	Time	Method
Acute toxicity rates of grade 3 gastrointestinal and hematologic toxicities (as raw percentage)	3 months after treatment	Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0

Secondary Outcome Measures

Name	Time	Method
Progression-free survival rates	1 year after treatment
Late toxicity rates of grade 2 gastritis, enteritis, fistula, and ulcer, or any other grade 3 or greater gastrointestinal (as raw percentage)	6 months, 9 months, and 1 year after treatment	Toxicities per CTCAE 4.0
Overall survival rates	1 year after treatment
Metastasis-free survival rates	1 year after treatment
Patient self-report of pain control	1 month and 3 months after treatment	Measured by Wong-Baker FACES 0-10 scale
Patient self-report of quality of life	1 month, 3 months, 6 months, 9 months, and 1 year after treatment	Measured by EORTC Quality of Life (QOL)-Q scale

Locations (2): Indiana University Health Hospital
🇺🇸
Indianapolis, Indiana, United States
Indiana University Health Melvin and Bren Simon Cancer Center
🇺🇸
Indianapolis, Indiana, United States