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Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body

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University of Cincinnati

Status

Completed

Conditions

Pancreatic Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02208024
UCCI-GI-002

Details and patient eligibility

About

The purpose of this study is to test the safety of focused radiation (Stereotactic Body Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.

Enrollment

18 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age >18 years.
  • Histologically confirmed pancreatic adenocarcinoma of the head and/or body; at least the majority of the histopathologic specimen must be identified as adenocarcinoma.
  • Pancreatic tumors must be considered resectable at time of treatment planning. Definition of resectable: no metastases, less than 180 degree involvement of superior mesenteric vein or portal vein, no involvement of hepatic artery, superior mesenteric artery or celiac artery
  • No active infection requiring hospitalization
  • Adequate labs
  • Life expectancy > 3 months.
  • Patient is to have received chemotherapy prior to enrollment. This will typically consist of 3-4 cycles of chemotherapy. Patients will have a 2 week break between last chemotherapy administration and start of SBRT.

Exclusion criteria

  • Presence of metastatic disease.
  • Infections requiring systemic antibiotic treatment.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Stereotactic Body Radiation Therapy
Experimental group
Description:
5 fractions of 6.6 Gy delivered twice weekly with each fraction separated by greater than 48 hours over 15 days
Treatment:
Radiation: Stereotactic Body Radiation Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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