Locally Advanced Pancreatic CancerSBRT-PC-01NCT03648632
Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)
A study testing Stereotactic Radiotherapy in people with Locally Advanced Pancreatic Cancer, run by Per Pfeiffer at 1 site in Denmark.
Trial summary
Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). A Danish phase II study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Stereotactic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Aug 2018to 31 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LAPC (Karolinska Type B, C or D1)
- Cytologically or histologically verified adenocarcinoma/carcinoma
- Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease
- The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)
- World Health Organization performance status 0-1
- Age ≥ 18 years
- Adequate hepatic function: bilirubin <3.0 x Upper Normal Limit, International Normalized Ratio <1.6, Activated Partial Thromboplastin Time < 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy
- Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.
Who cannot join
- M1 disease
- Prior radiotherapy to abdominal cavity
- Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
- Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study
Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).
A Danish phase II study.
Read the detailed description
Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT.
The sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect.
A resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies.
To ensure 25 evaluable patients the investigators will include a total of 30 patients.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Stereotactic Radiotherapy
- Keywords
- Stereotactic Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiotherapyRadiation
Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiotherapy | Experimental | 50 Gy in 5 fractions within a total of 7 - 8 days Receives: Radiation: Stereotactic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection rate for all patients starting SBRT
Resection rate for all patients starting SBRT
Measured: 12 month
Secondary outcomes (7)
1 year survival for all patients starting SBRT
1 year survival for all patients starting SBRT
Measured: 12 month
Progression-free survival (PFS)
PFS will be calculated from the date of registration to the date of documented progressive disease
Measured: 12 month
Overall survival (OS)
OS will be calculated from the date of registration to the date of documented progressive disease
Measured: 12 month
Adverse events grade 2-5 (NCI-CTCAE 4.1)
Adverse events grade 2-5 (NCI-CTCAE 4.1)
Measured: 12 month
Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)
Complication rate will be gathered.
Measured: 30 days
Mortality
Mortality rate
Measured: 30 days
Mortality
Mortality rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start22 Aug 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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 Locally Advanced Pancreatic CancerStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Pfeiffer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, Professor, Principal investigator, Odense Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648632
- Sponsor's protocol ID
- KFE 18.13
- Acronym
- SBRT-PC-01
- Status last verified
- Apr 2022
- First submitted
- 20 Jun 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weisz Ejlsmark M, Bahij R, Schytte T, Ronn Hansen C, Bertelsen A, Mahmood F, Bau Mortensen M, Detlefsen S, Weber B, Bernchou U, Pfeiffer P. Adaptive MRI-guided stereotactic body radiation therapy for locally advanced pancreatic cancer - A phase II study. Radiother Oncol. 2024 Aug;197:110347. doi: 10.1016/j.radonc.2024.110347. Epub 2024 May 28.
PubMed 38815694
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study
- ClinicalTrials.gov ID
- NCT03648632
- Acronym / sponsor ID
- SBRT-PC-01 / KFE 18.13
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- Stereotactic Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Per PfeifferUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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.
Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).
A Danish phase II study.
Detailed description
Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT.
The sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect.
A resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies.
To ensure 25 evaluable patients the investigators will include a total of 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiotherapy | Experimental | Radiation: Stereotactic Radiotherapy50 Gy in 5 fractions within a total of 7 - 8 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- LAPC (Karolinska Type B, C or D1)
- Cytologically or histologically verified adenocarcinoma/carcinoma
- Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease
- The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)
- World Health Organization performance status 0-1
Key exclusion criteria (4 listed)
- M1 disease
- Prior radiotherapy to abdominal cavity
- Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
- Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
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 |
|---|---|---|
| Stereotactic RadiotherapyPatients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days. | Radiation | Stereotactic Radiotherapy |
Primary outcome
Resection rate for all patients starting SBRT
Time frame: 12 month
Resection rate for all patients starting SBRT
7 secondary outcomes
1 year survival for all patients starting SBRT
Time frame: 12 month
Progression-free survival (PFS)
Time frame: 12 month
Overall survival (OS)
Time frame: 12 month
Adverse events grade 2-5 (NCI-CTCAE 4.1)
Time frame: 12 month
Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)
Time frame: 30 days
Mortality
Time frame: 30 days
Mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 38815694Weisz Ejlsmark M, Bahij R, Schytte T, Ronn Hansen C, Bertelsen A, Mahmood F, Bau Mortensen M, Detlefsen S, Weber B, Bernchou U, Pfeiffer P. Adaptive MRI-guided stereotactic body radiation therapy for locally advanced pancreatic cancer - A phase II study. Radiother Oncol. 2024 Aug;197:110347. doi: 10.1016/j.radonc.2024.110347. Epub 2024 May 28.
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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.
Per Pfeiffer, Professor principal investigator
Odense Universitetshospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiotherapy in people with Locally Advanced Pancreatic Cancer, run by Per Pfeiffer at 1 site in Denmark.
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 8 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: finished, as of the sponsor's last update on 20 Apr 2022. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resection rate for all patients starting SBRT (time frame: 12 month). 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 NCT03648632, 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 20 Apr 2022.