Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— SBRT  

Official title:

Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454140
• Other study ID #: 140103
• Status: Completed
• Phase: N/A
• Start date: June 20, 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• SBRT
Fixed five-fraction stereotactic radiotherapy

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.	From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years
Secondary	Local Tumor Progression	local tumor control remains a crucial part of treatment for patients with pancreatic cancer who are not candidates for curative therapy.	From date of randomization until local disease progression defined as a =20% increase in size on CT compared with CT prior to SBRT assessed over 3 years
Secondary	Distant Metastatic Progression Rate	The cumulative incidence of distant metastatic failure will be determined for all patients treating death as a competing risk. In patients initially presenting with locally advanced disease, distant disease progression will be defined as the appearance of new metastatic lesions. In patients presenting with metastatic disease, distant progression will be defined as a =20% increase in size on CT of the previously noted metastatic lesions.	From date of randomization until the appearance of new lesions or a =20% increase in size on CT of the previously noted metastatic lesions assessed over 3 years
Secondary	Overall Survival	Overall survival will be measured from the date of diagnosis through death of any cause. Survival will also be reported from the date of SBRT for comparisons to other trials in the literature. Finally, survival will be stratified by those with locally advanced disease, and those with metastatic disease on presentation.	From date of diagnosis and SBRT to date of death assessed over 3 years