Pancreatic Carcinoma Non-resectableNCT01872377
Dose Escalation Study of CyberKnife® SBRT Boost for Patients With Unresectable Locally Advanced Pancreatic Cancer
A study testing CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost in people with Pancreatic Carcinoma Non-resectable, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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 at all. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pancreatic Carcinoma Non-resectable
- What is being tested?
- CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to 16 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Time-to-Event Continual Reassessment (TITE-CRM) Dose Escalation Trial of CyberKnife® Stereotactic Body Radiotherapy (SBRT) Boost With Concurrent Chemoradiotherapy 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.
Read more
The purpose of this study is to test the safety of adding a higher dose (a "boost" 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.
Read the 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 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.
- Conditions
- Pancreatic Carcinoma Non-resectable
- Being tested
- CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost
- Keywords
- pancreas, pancreatic, unresectable, CyberKnife, SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife® Stereotactic Body Radiotherapy(SBRT)BoostRadiation
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 assigned according to Time-to-Event Continual Reassessment Method (TITE-CRM). Three fractions of various dose levels would be delivered over 5 to 10 days (typically Monday, Wednesday and Friday) with at least 36 hours between two sessions. In case of technical or medical problem, the authorized total treatment time is 12 days.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy Boost | Experimental | 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 either receiving 6, 7, 8, 9 or 10 Gy X 3Fr. Receives: Radiation: CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJul 2013
- Primary completion16 May 2018
- Study completion16 May 2018
Why it stopped: No longer recruiting patients to this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Carcinoma Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Pantarotto, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872377
- Sponsor's protocol ID
- 20120384-01H
- Other IDs
- OTT 12-04
- Status last verified
- Apr 2020
- First submitted
- 12 Oct 2012
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Time-to-Event Continual Reassessment (TITE-CRM) Dose Escalation Trial of CyberKnife® Stereotactic Body Radiotherapy (SBRT) Boost With Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01872377
- Acronym / sponsor ID
- 20120384-01H
- Conditions
- Pancreatic Carcinoma Non-resectable
- Keywords
- pancreas, pancreatic, unresectable, CyberKnife, SBRT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer recruiting patients to this study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 "boost" 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy Boost | Experimental | Radiation: CyberKnife® Stereotactic Body Radiotherapy(SBRT)BoostAll 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 either receiving 6, 7, 8, 9 or 10 Gy X 3Fr. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberKnife® Stereotactic Body Radiotherapy(SBRT)BoostStereotactic 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 assigned according to Time-to-Event Continual Reassessment Method (TITE-CRM). Three fractions of various dose levels would be delivered over 5 to 10 days (typically Monday, Wednesday and Friday) with at least 36 hours between two sessions. In case of technical or medical problem, the authorized total treatment time is 12 days. | Radiation | Radiotherapy Boost |
Primary outcome
Toxicity defined as grade 3 or 4 gastro-intestinal or other non-haematological toxicity
Time frame: up to 3 years
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
2 secondary outcomes
CT scans will measure tumour response
Time frame: 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
Time frame: up to 7 years
Results and safety
The study was stopped early (reason given: No longer recruiting patients to this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
Related trials for Pancreatic Carcinoma Non-resectable
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
Active, not recruitingPhase 1
Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery
Locally Advanced Pancreatic Adenocarcinoma, Pancreatic Acinar Cell Carcinoma
Active, not recruitingPhase 2
Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors, the ComPareNET Trial
Metastatic Pancreatic Neuroendocrine Tumor, Unresectable Pancreatic Neuroendocrine Carcinoma
RecruitingPhase 1
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
RecruitingObservational study
EUS Procedures Using RIVOS™ EUS Access Device
Pancreatic Fluid Collections, Biliary Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Pantarotto, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost in people with Pancreatic Carcinoma Non-resectable, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No longer recruiting patients to this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity defined as grade 3 or 4 gastro-intestinal or other non-haematological toxicity (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.