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

NCT02780648 | Completed Results DMC FDA Device

• 2 other identifiers: IUSCC-05651601638414
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Neoplasms

Keywords

stereotactic radiotherapy; pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)

  Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

  Up to 90 days after treatment

Secondary Outcomes (8)

• Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)

  90 or more days after treatment, up to 7 years

• Overall Survival

  1 year after treatment

• Progression-Free Survival

  1 year after treatment

• Metastasis-Free Survival

  1 year after treatment

• Wong-Baker FACES Pain Rating Score

  Baseline (before treatment), Week 1 (during treatment), Week 2 (during treatment), Month 1 (after treatment), and Month 3 (after treatment)

Study Arms (1)

Stereotactic Body Radiation

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation

Interventions

Stereotactic Body Radiation RADIATION

Stereotactic Body Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Karnofsky Performance Status \>70%
• Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least the majority of the histopathologic specimen must be identified as adenocarcinoma as opposed to another histologic subtype. In patients with a diagnosis of recurrent disease (based on radiographic progression and/or rising CA19-9 levels) and a history of a biopsy-proven adenocarcinoma of the pancreas or the ampulla of Vater, repeat biopsy of the recurrence site is not required for participation of the trial.
• Pancreatic or periampullary tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning.
• Patients who have been treated with any combination of surgical resection and neoadjuvant/adjuvant conventional chemoradiation therapy for resectable disease or conventional chemoradiation as definitive treatment for unresectable or borderline resectable disease are eligible for the study, provided that at least 180 days have elapsed since completing any previous radiation treatment. Patients who have been receiving continued chemotherapy following their initial radiation treatment are eligible regardless of when the most recent chemotherapy was received. Those patients who have received prior radiation therapy will constitute Cohort A and will receive stereotactic body radiation (SBRT) as 5 gray (Gy) x 5.
• Patients who have not previously undergone radiation therapy can have a history of treatment with either chemotherapy (for unresectable/borderline resectable disease) or any combination of surgery and chemotherapy (for resectable disease). Patients with no history of prior radiation treatment will constitute Cohort B and will receive SBRT as 6.6 Gy x 5. Please note that patients must have received at least two cycles of chemotherapy (with selection of drugs at the discretion of the treating oncologist) before SBRT treatment on protocol.
• Acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy):
• Leukocytes \>3,000/μL
• Absolute neutrophil count \>1,500μL
• Platelets \>100,000/μL
• Total Bilirubin ≤1.5x institutional upper limit of normal
• Aspartate transaminase (AST(SGOT))/Alanine transaminase (ALT(SGPT)) \<2.5x institutional upper limit of normal
• Creatinine ≤ institutional upper limit of normal OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Ability to understand and the willingness to sign a written informed consent document.
• Life expectancy \> 3 months.

You may not qualify if:

• Age \< 18 years.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix. Patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for \> 5 years will be allowed to enter the trial.
• Pregnant and breastfeeding women are excluded as are women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test.
• Patients with a life expectancy of \< 3 months.
• Patients with metastatic disease.
• Patients with evidence of gross tumor invasion into the lumen of the stomach or small bowel are not eligible; if imaging suggests luminal invasion of tumor, this must be ruled out endoscopically before the patient can be enrolled on study.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Robert Miller
• Organization: IndianaU

millro@iu.edu

317-944-1317

Study Officials

• Robert Miller, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Radiation Oncology

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 23, 2016
• Study Start: May 1, 2016
• Primary Completion: December 17, 2019
• Study Completion: May 15, 2025
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)