Pancreatic CancerPhase 2NCT01898741
Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
A Phase 2 study testing 24 Gy in 3 fractions in people with Pancreatic Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 24 Gy in 3 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2013to Jul 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III)
- Not eligible for operation with curative intent
- >18 years
- Written informed consent
Who cannot join
- WHO performance status 3-4
- Expected life span <3 months
- Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
- Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
M. van Vulpen, Prof MD PhD, +31 88 755 8800, m.vanvulpen@umcutrecht.nl
M. van Vulpen, Prof MD PhD
About this study
Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.
Read the detailed description
Objective of the study:
To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma
Study design:
Pilot study to determine safety and feasibility
Study population:
Patients with locally advanced pancreatic carcinoma, without distant metastasis
Intervention:
Patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. Radiotherapy will be delivered in three fractions of 8 Gy on an outpatient basis.
Primary study outcome:
The main study endpoint will be safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation.
Secondary study outcome:
Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Increased severe toxicity may occur due to the intervention, but treatment related toxicity should be limited due to strict dose constraints to the organs at risk (e.g. duodenum, stomach). Potential benefits may be pain relief, due to local control of the tumor, and a prolonged survival.
- Conditions
- Pancreatic Cancer
- Being tested
- 24 Gy in 3 fractions
- Keywords
- Pancreatic cancer, Radiotherapy, SBRT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 Gy in 3 fractionsRadiation
| Study group | Role | What they receive |
|---|---|---|
| irradiation | Experimental | 24 Gy in 3 fractions Receives: Radiation: 24 Gy in 3 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation
Measured: 90 days of last irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. van Vulpen, UMC Utrecht
- Investigators
- M. van Vulpen, Prof MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898741
- Sponsor's protocol ID
- UMCU-12-628
- Status last verified
- Feb 2015
- First submitted
- 9 Jul 2013
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heerkens HD, van Vulpen M, Erickson B, Reerink O, Intven MP, van den Berg CA, Molenaar IQ, Vleggaar FP, Meijer GJ. MRI guided stereotactic radiotherapy for locally advanced pancreatic cancer. Br J Radiol. 2018 Nov;91(1091):20170563. doi: 10.1259/bjr.20170563. Epub 2018 Jul 31.
PubMed 30063383
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01898741
- Acronym / sponsor ID
- UMCU-12-628
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Radiotherapy, SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 12 Jul 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.
Pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. High dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. In this study, we want to evaluate safety and technical feasibility for cone beam CT guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.
Detailed description
Objective of the study:
To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma
Study design:
Pilot study to determine safety and feasibility
Study population:
Patients with locally advanced pancreatic carcinoma, without distant metastasis
Intervention:
Patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. Radiotherapy will be delivered in three fractions of 8 Gy on an outpatient basis.
Primary study outcome:
The main study endpoint will be safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation.
Secondary study outcome:
Other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Increased severe toxicity may occur due to the intervention, but treatment related toxicity should be limited due to strict dose constraints to the organs at risk (e.g. duodenum, stomach). Potential benefits may be pain relief, due to local control of the tumor, and a prolonged survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irradiation | Experimental | Radiation: 24 Gy in 3 fractions24 Gy in 3 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Locally advanced pancreatic tumors (stage III) or medically inoperable patients with pancreatic cancer (stage I, II, or III)
- Not eligible for operation with curative intent
- >18 years
- Written informed consent
Key exclusion criteria (4 listed)
- WHO performance status 3-4
- Expected life span <3 months
- Previous chemotherapy, pancreatic surgery or pancreatic radiotherapy
- Exclusion criteria for contrast enhanced MRI and/or CT scan, following the protocol of the department of radiology UMCU
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 |
|---|---|---|
| 24 Gy in 3 fractions | Radiation | irradiation |
Primary outcome
Safety
Time frame: 90 days of last irradiation
Safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the CTC-AE 4.0 due to the complete procedure within 90 days of the last radiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Derived from this study: PubMed 30063383Heerkens HD, van Vulpen M, Erickson B, Reerink O, Intven MP, van den Berg CA, Molenaar IQ, Vleggaar FP, Meijer GJ. MRI guided stereotactic radiotherapy for locally advanced pancreatic cancer. Br J Radiol. 2018 Nov;91(1091):20170563. doi: 10.1259/bjr.20170563. Epub 2018 Jul 31.
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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.
M. van Vulpen, Prof MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 24 Gy in 3 fractions in people with Pancreatic Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2015. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M. van Vulpen, Prof MD PhD (+31 88 755 8800, m.vanvulpen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 90 days of last irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01898741, which also lists 1 linked publication.
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 3 Feb 2015.