Neuroendocrine Carcinoma of PancreasPhase 1/2FIBROPANC-1NCT05641233
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
A Phase 1/2 study testing Stereotactic radiotherapy in people with Neuroendocrine Carcinoma of Pancreas and Duodenum Carcinoma, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm
- 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
- 33 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Dec 2020to 1 Mar 2023
- Phase
- Phase 1/2
- 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
- Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.
- Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site).
- WHO-ECOG performance status 0,1 or 2.
- Ability to undergo stereotactic radiotherapy and surgery.
- Age ≥ 18 years.
- Good understanding of the oral and written patient information provided.
- Written informed consent.
Who cannot join
- Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.
- Patients with (a history of) chronic pancreatitis
Trial locations and contacts
2 sites in 1 country.
Tessa Hendriks contact
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland
Tessa Hendriks, t.e.hendriks@amsterdamumc.nl
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland
Leonoor Wismans, l.wismans@erasmusmc.nl
About this study
Official title: Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.
- Conditions
- Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm, Distal Cholangiocarcinoma, GIST, Pancreas Fibrosis
- Being tested
- Stereotactic radiotherapy
- Keywords
- Post operative pancreatic fistula, Stereotactic radiotherapy, Pancreatic fibrosis, Pancreatoduodenectomy
- Medical subject headings
- Duodenal Neoplasms, Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapyRadiation
Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Radiation: Stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - CTCAE grade 3-4-5 complications related to the intervention
Measured: Up to 30 days after surgery
Hardness of pancreas texture, determined by Durometer measurement
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
Measured: Histopathological assesment of tissue after surgery
Secondary outcomes (8)
Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C
Defined by the ISGPS guideline (2016)
Measured: Up to 30 days after operation
Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon
Texture is scaled as soft/intermediate/hard
Measured: Assesment during surgery
Macroscopic tissue assessment, determined by the pathologist
Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue
Measured: Histopathological assesment after surgery
Surgery related postoperative complications defined according to the Clavien-Dindo classification
Measured: Up to 30 days after surgery
Overall complications
Measured: Up to 30 days after surgery
Readmission rate
Measured: Postoperative period
Length of hospital stay
Days
Measured: Up to 30 days after surgery
30-day mortality and in-hospital mortality
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Dec 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (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 Neuroendocrine Carcinoma of PancreasStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper H.J. van Eijck, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641233
- Sponsor's protocol ID
- NL72913.018.20
- Acronym
- FIBROPANC-1
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suurmeijer JA, Wismans LV, Hendriks TE, Bruynzeel AM, Nuyttens JJ, Intven MPW, van Driel LMJW, Groot Koerkamp B, Busch OR, Stoker JJ, Verheij J, Farina A, Doukas M, de Hingh IHJ, Lips DJ, van der Harst E, van Tienhoven G, Besselink MG, van Eijck CHJ; Dutch Pancreatic Cancer Group. Feasibility, safety and preliminary efficacy of preoperative stereotactic radiotherapy on the future pancreatic neck transection margin to reduce the risk of pancreatic fistula after high-risk pancreatoduodenectomy (FIBROPANC): protocol for a multicentre, single-arm trial. BMJ Open. 2024 Sep 24;14(9):e087193. doi: 10.1136/bmjopen-2024-087193.
PubMed 39317507
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy: a Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT05641233
- Acronym / sponsor ID
- FIBROPANC-1 / NL72913.018.20
- Conditions
- Neuroendocrine Carcinoma of Pancreas, Duodenum Carcinoma, Pancreas Neoplasm, Distal Cholangiocarcinoma, GIST, Pancreas Fibrosis
- Keywords
- Post operative pancreatic fistula, Stereotactic radiotherapy, Pancreatic fibrosis, Pancreatoduodenectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 7 Dec 2022 (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.
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Radiation: Stereotactic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.
- Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site).
- WHO-ECOG performance status 0,1 or 2.
- Ability to undergo stereotactic radiotherapy and surgery.
- Age ≥ 18 years.
Key exclusion criteria (2 listed)
- Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.
- Patients with (a history of) chronic pancreatitis
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 radiotherapyPreoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site. | Radiation | Intervention arm |
Primary outcome
Safety - CTCAE grade 3-4-5 complications related to the intervention
Time frame: Up to 30 days after surgery
Hardness of pancreas texture, determined by Durometer measurement
Time frame: Histopathological assesment of tissue after surgery
Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO
8 secondary outcomes
Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C
Time frame: Up to 30 days after operation
Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon
Time frame: Assesment during surgery
Macroscopic tissue assessment, determined by the pathologist
Time frame: Histopathological assesment after surgery
Surgery related postoperative complications defined according to the Clavien-Dindo classification
Time frame: Up to 30 days after surgery
Overall complications
Time frame: Up to 30 days after surgery
Readmission rate
Time frame: Postoperative period
Length of hospital stay
Time frame: Up to 30 days after surgery
30-day mortality and in-hospital mortality
Time frame: Up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 39317507Suurmeijer JA, Wismans LV, Hendriks TE, Bruynzeel AM, Nuyttens JJ, Intven MPW, van Driel LMJW, Groot Koerkamp B, Busch OR, Stoker JJ, Verheij J, Farina A, Doukas M, de Hingh IHJ, Lips DJ, van der Harst E, van Tienhoven G, Besselink MG, van Eijck CHJ; Dutch Pancreatic Cancer Group. Feasibility, safety and preliminary efficacy of preoperative stereotactic radiotherapy on the future pancreatic neck transection margin to reduce the risk of pancreatic fistula after high-risk pancreatoduodenectomy (FIBROPANC): protocol for a multicentre, single-arm trial. BMJ Open. 2024 Sep 24;14(9):e087193. doi: 10.1136/bmjopen-2024-087193.
- Individual participant dataSharing planned: No
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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.
Tessa Hendriks contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic radiotherapy in people with Neuroendocrine Carcinoma of Pancreas and Duodenum Carcinoma, run by Erasmus Medical Center at 2 sites 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 7 inclusion and 2 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Leonoor Wismans (010-703 38 54, l.wismans@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - CTCAE grade 3-4-5 complications related to the intervention (time frame: Up to 30 days after surgery). The study lists 2 primary outcomes in all. 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 NCT05641233, 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 7 Dec 2022.