Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer (SBRT)

University of California San Diego

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02454140

140103

Details and patient eligibility

About

This study is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.

Full description

This trial is designed to find the maximum tolerated dose of radiation under a fixed 5-fraction SBRT regimen escalating the dose from 40 Gy in 5 fractions, to 60 Gy in 5 fractions, at 5 Gy intervals.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas.
• Disease Status: Medically unresectable (any stage), or locally advanced (stage III).
• Tumor Location: Primary tumor may be located anywhere in the pancreas.
• Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol.
• Performance Level: Karnofsky Performance Status ≥ 60
• Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal
• Informed Consent: All subjects must sign a written informed consent.

Exclusion criteria

• Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
• Life expectancy < 6 months
• The patient cannot have had prior radiation therapy to the thorax or upper abdomen.
• Incarcerated individuals
• Subjects unable to give informed consent

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Cohort 1

Experimental group

Description:

SBRT 40 Gy in 5 fractions

Treatment:

Radiation: SBRT

Cohort 2

Experimental group

Description:

SBRT 45 Gy in 5 fractions (starting dose level)

Treatment:

Radiation: SBRT

Cohort 3

Experimental group

Description:

SBRT 50 Gy in 5 fractions

Treatment:

Radiation: SBRT

Cohort 4

Experimental group

Description:

SBRT 55 Gy in 5 fractions

Treatment:

Radiation: SBRT

Cohort 5

Experimental group

Description:

SBRT 60 Gy in 5 fractions

Treatment:

Radiation: SBRT