Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347618
• Other study ID #: UGIP14107
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: April 13, 2022

Study information

• Verified date: July 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.

Description:

This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas

2. CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration

3. CT chest or PET/CT within 6 weeks prior to registration

4. Clinically determined to be resectable based on NCCN Criteria:

5. No radiographic evidence of superior mesenteric vein or portal vein distortion

6. No evidence of distant metastasis

7. Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery

8. No enlarged lymph nodes per CT criteria or PET avid lymph nodes

9. No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)

10. Adequate cardiopulmonary reserves to tolerate surgery

11. Karnofsky performance status > 70

12. Age >18

13. Adequate bone marrow function defined as follows:

14. Absolute neutrophil count (ANC) > 1800 cells/mm3

15. Platelets = 100,000 cells/mm3

16. Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)

17. Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry

18. Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

1. Prior surgical resection of any pancreatic malignancy

2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

3. Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.

4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

5. Severe, active comorbidity, defined as follows:

1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months

2. Transmural myocardial infarction within the last 6 months

3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.

6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure

7. Any evidence of distant metastases (M1)

8. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Preoperative SBRT
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade 2 or greater toxicity	Number of incidence of grade 2 or greater toxicity	2 years
Secondary	Number of Participants with no further growth of cancer at original site (Local control)	Count subjects with no further growth of cancer at original site.	2 years
Secondary	Count subjects with Recurrence of cancer in other body sites	Compare recurrence locations of treated patients relative to historical controls.	2 years
Secondary	Time to Progression of pancreatic cancer	Duration of progression free survival of treated patients	4 years
Secondary	Time to death	Measure duration of survival of treated patients.	4 years