Status:
TERMINATED
Dose Escalation Study of CyberKnife® SBRT Boost for Patients With Unresectable Locally Advanced Pancreatic Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Pancreatic Carcinoma Non-resectable
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
Currently the standard treatment for locally advanced, unresectable pancreatic cancer consists either of chemotherapy by itself or a combination of chemotherapy plus radiation therapy or no treatment ...
Detailed Description
Stereotactic body radiotherapy (SBRT) is a minimally invasive treatment technique that allows for ultra-high doses of radiation to be delivered to small areas with precision not previously possible us...
Eligibility Criteria
Inclusion
- Histological or Pathologically confirmed pancreatic adenocarcinoma
- T1 - T4 or N0-N1 pancreatic adenocarcinoma
- ECOG performance status ≤ 2
- Male and female, aged ≥ 19- 80 years
- Signed study-specific informed consent
- General condition considered feasible for radiotherapy
- INR ≤1.5 within 7 days prior to fiducial placement
Exclusion
- Diagnosis of distant metastatic disease
- Primary tumor \> 5 cm in maximum diameter on any imaging modality
- \>3 involved lymph nodes as per staging CT and/or PET-CT
- Clear indication of involvement of duodenal wall on imaging or at time of endoscopy
- Evidence of peritoneal carcinomatosis, portal vein occlusion, ascites or involvement of non-regional lymph nodes
- Histology clearly other than adenocarcinoma
- Disease cannot be radiographically assessed due to patient related contraindications or due to lack of visible tumor on pre-treatment imaging
- More than 1 prior chemotherapy regimen for pancreatic cancer or treatment for \>6 months
- Prior radiotherapy exposure that would overlap the anticipated study treatment fields
- Treatment with any other investigational agent, within 30 days prior to entering this study
- Prior chemotherapy for pancreatic cancer is permitted, although there should be 30 days between last dose and start of treatment on protocol
- Past or current history of other malignancies (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission for a minimum of 2 years from treatment start
- Life expectancy \< 12 months
- Inability or unwillingness to comply with the protocol
- Any medical condition which, in the opinion of the treating radiation oncologist, would make a radical course of radiotherapy to the upper abdomen unsafe
- Pregnancy or lactation
- Positive serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women \< 2 years after the onset of menopause.
- Female participants that are of childbearing potential unwilling or unable to use effective means of contraception while receiving the study interventions and 30 days after receiving the last dose of study interventions
- Male participants ,unwilling or unable, or whose female partner is unwilling or unable, to use effective means of contraception while the participant is receiving the study interventions and 30 days after receiving the last dose of study interventions
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01872377
Start Date
July 1 2013
End Date
May 16 2018
Last Update
April 15 2020
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H8L6