Dose Escalation Study Of CyberKnife® SBRT Boost For Patients With Unresectable Locally Advanced Pancreatic Cancer

Study Overview

Dose Escalation Study of CyberKnife® SBRT Boost for Patients With Unresectable Locally Advanced Pancreatic Cancer

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 at all. Unfortunately, no treatment thus far has been able to provide patients with a consistent chance for a cure although there are rare patients who will live for many years after treatment. For most patients the chemotherapy or chemotherapy plus radiation will maintain or improve quality of life by keeping the cancer under control for a period of time. Approximately 25-30% of patients with early pancreatic cancer who are able to have the cancer completely removed surgically will live beyond 5 years and will be considered cured. This tells us that aggressive treatment directed at the tumour in the pancreas can lead to cure. For the majority of patients who can not have an operation, giving more radiation as part of the treatment may be a strategy that results in better control of the tumour in the pancreas which may or may not result in patients living longer. The purpose of this study is to test the safety of adding a higher dose (a ȫoost" dose) of radiation using a radiation unit called CyberKnife when combined with standard chemotherapy and radiation for patients with locally advanced, unresectable pancreatic cancer. Participants on this study will receive a 'boost' dose of radiation which consists of 3 treatments over 1 week. The participants will then receive the standard of care treatment of chemotherapy and standard radiation therapy over a 5 week period, which will be followed by the conventional 20 weeks of chemotherapy alone. The participants will then be followed for progression of disease and toxicity related to the boost treatment for up to 5 years.

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 using older equipment. The CyberKnife® Robotic Radiosurgery System (Accuray, Sunnyvale California, USA) is a radiation unit specifically designed to focus beams of radiation accurately anywhere in the body. It is able to track, detect and correct for any tumor movement during treatment by using a sophisticated image guidance system.

Pancreatic Carcinoma Non-resectable

RADIATION: CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost

20120384-01H
OTT 12-04

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-10-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-04-13
First Submitted that Met QC Criteria 2013-06-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-04-15
First Posted (ACTUAL) 2013-06-07	Results First Posted N/A	Last Verified 2020-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Radiotherapy Boost All participants will receive the CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost treatment however, there are 5 dose levels that could be assigned according to Time-to-Event Continual Reassessment Method (TITE-CRM). Participants will be assigned to	RADIATION: CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost 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. In this study all participants will receive one of 5 dose levels that will be as

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Radiotherapy Boost

All participants will receive the CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost treatment however, there are 5 dose levels that could be assigned according to Time-to-Event Continual Reassessment Method (TITE-CRM). Participants will be assigned to

RADIATION: CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost

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. In this study all participants will receive one of 5 dose levels that will be as

Primary Outcome Measures	Measure Description	Time Frame
Toxicity defined as grade 3 or 4 gastro-intestinal or other non-haematological toxicity	Toxicity defined as grade 3 or 4 gastro-intestinal or other non-haematological toxicity felt to be related to radiotherapy to the upper abdomen, graded as per CTCAE 4.0 and occuring between 3 and 9 months post CyberKnife radiotherapy	up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
CT scans will measure tumour response	Participant recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR), and overall survival (OS) will be measured using CT scans at 3 month intervals during the first 9 months post CyberKnife radiotherapy and then 6 month intervals during the remainder of follow up phase.	up to 7 years
CyberKnife radiation dose measured in Gy delivered to the tumour and surrounding organs vs. the frequency of grade 3-4 toxicity defined by CTCAE v4.0	To establish radiation dose-volume relationships for various organs and toxicity.	up to 7 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jason Pantarotto, MD, The Ottawa Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record