Pancreatic NeoplasmsPhase 2CKPancreasNCT03199144
Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer
A Phase 2 study testing Chemotherapy, Stereotactic radiotherapy and Surgery in people with Pancreatic Neoplasms, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
Trial summary
The goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Chemotherapy, Stereotactic radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteLuxembourg
- Study dates
- 20 Apr 2017to 19 Mar 2021
- 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
- Biopsy proven pancreatic adenocarcinoma
- Borderline resectable pancreatic adenocarcinoma (NCCN guidelines)
- OMS status ≤2
- Age at presentation >18 y
- Absolute neutrophil counts >1500/ml
- Absolute platelet count >100000/ml
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- GOT and GPT <2.5 x the upper limit of normal
- Total bilirubin < the upper limit of normal
- Serum creatinin < upper limit of normal
- Coagulation test within limit of normal (Prothrombin time, INR) +/- 15%
- No evidence of jaundice at enrolment. If stent required to alleviate jaundice it should be metallic
- Patient must be able to eat without a feeding tube and can take medications orally
- Disease must be encompassed in a reasonable radiation field
- Signed informed consent
Who cannot join
- Distant metastases
- Evolutive disease after the neoadjuvant chemotherapy course according RECIST criteria
- Neuroendocrine tumors
- Peritoneal dissemination visualized at diagnostic abdominal CT scan
- Pathologic abdominal nodes visualized at diagnostic abdominal CT scan outside the pancreatic area
- Pathologic PET scan outside the pancreatic area
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- Inoperability for medical reasons
- Inability to tolerate chemotherapy for medical (in particular grade II or more neuropathy) or allergic purposes, or for OMS score >2
- Inability to tolerate Whipple resection
- Collagenose diseases
- Cancer evolution outside the pancreatic bed at the PET scanner performed just after the 3 neo adjuvant chemotherapy cycles
- Any previous cancer in the 5 years excepted a basal skin cell carcinoma or in situ cervical cancer
- Active infection with HIV, Hepatitis B or c
- Pregnant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Borderline Resectable Pancreatic Cancer : Phase II Study
The goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described.
Read the detailed description
- Chemotherapy : 3 cycles of Gemzar-Abraxane. Nab-Paclitaxel will be delivered at day 1 at the dose of 125mg/m2. Gemcitabine will be delivered at the dose of 1g/m2 at days 1, 8 and 15. Three cycles will be given at 4 weeks intervals.
- PET Scanner and Magnetic resonance Imaging within the 10 days of the third chemotherapy cycle
3.Radiation treatment: Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days, according to the ongoing "CYM 6 Spinal CFB1" which was approved by the "Centre National d'Ethique et de Recherches" (CNER) under the Number 20013/1103 (Ongoing Study 3).
At first, 4 coïl fiducials will be placed inside and/or around the tumor. 10 days later the imaging preparation procedure will be initiated with a CT Scan and MRI simulation. Both exams will be fused using the fiducials. The Clinical Target Volume (CTV) will include systematically the coeliac trunk until the aorta with a margin of at least 1 cm, the origin of the upper mesenteric vessels until the aorta with at least a margin of 1 cm, the space between the Inferior Cava Vein (ICV) and the aorta in front of the pancreatic region, the space between the portal vein and ICV and finally the right lateral border of the ICV in front of the pancreatic region in case of pancreatic head tumors only. The CTV will also include the tumor mass with a 1 cm margin and the locally positive CT scan or PET scanner nodes with a margin of 1 cm provided it does not overlay the digestive structures that will remain after the surgical resection. Finally all these regions will be linked to make a unique CTV structure. The PTV will be defined as an expansion of 5 mm from the CTV. The doses tolerated to the organs at risk figure in the Ongoing Study 3.
Radiation treatment will be initiated 4 weeks after the third chemotherapy cycle.
- Surgery : Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location. The extension degree of the resection will remain at the discretion of the surgeon. However all the bowel and duodenum irradiated at the prescription dose will be systematically removed whatever the importance of the surgical resection.
Minimal Follow up :
- Clinical exam every 3 months for 3 years
- Thoraco-abdominal CT scan at 6, 12, 18, 24, 30 and 36months
- PET Scanner at 6, 12, 18, 24, 30 and 36months
- CA 19.9 every 3 months for 3 years
- Conditions
- Pancreatic Neoplasms
- Being tested
- Chemotherapy, Stereotactic radiotherapy, Surgery
- Keywords
- Pancreatic Neoplasms, Borderline resectable, Neoadjuvant treatment, Chemotherapy, Stereotactic radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
3 cycles of Gemzar-Abraxane
Stereotactic radiotherapyRadiation
Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days
SurgeryProcedure or surgery
Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiotherapy | Experimental | Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days Receives: Drug: Chemotherapy; Radiation: Stereotactic radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient overall survival
patient overall survival
Measured: follow up during 3 years after patient inclusion
Secondary outcomes (4)
positive surgical margins
assessment of R1 margin defined according to the British Royal College of pathology
Measured: follow up during 3 years after patient inclusion
toxicity according the CTCAEv4
toxicity according the CTCAEv4
Measured: follow up during 3 years after patient inclusion
CA19.9 level post operatively
CA19.9 levels post operatively
Measured: follow up during 3 years after patient inclusion
CEA level post operatively at one month
CEA level post operatively at one month
Measured: follow up during 1 month after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start20 Apr 2017
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Why it stopped: difficulties to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse, Luxembourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199144
- Sponsor's protocol ID
- Pancreas cancer neoadjuvant
- Acronym
- CKPancreas
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2017
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Borderline Resectable Pancreatic Cancer : Phase II Study
- ClinicalTrials.gov ID
- NCT03199144
- Acronym / sponsor ID
- CKPancreas / Pancreas cancer neoadjuvant
- Conditions
- Pancreatic Neoplasms
- Keywords
- Pancreatic Neoplasms, Borderline resectable, Neoadjuvant treatment, Chemotherapy, Stereotactic radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 26 Jun 2017 (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 goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described.
Detailed description
- Chemotherapy : 3 cycles of Gemzar-Abraxane. Nab-Paclitaxel will be delivered at day 1 at the dose of 125mg/m2. Gemcitabine will be delivered at the dose of 1g/m2 at days 1, 8 and 15. Three cycles will be given at 4 weeks intervals.
- PET Scanner and Magnetic resonance Imaging within the 10 days of the third chemotherapy cycle
3.Radiation treatment: Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days, according to the ongoing "CYM 6 Spinal CFB1" which was approved by the "Centre National d'Ethique et de Recherches" (CNER) under the Number 20013/1103 (Ongoing Study 3).
At first, 4 coïl fiducials will be placed inside and/or around the tumor. 10 days later the imaging preparation procedure will be initiated with a CT Scan and MRI simulation. Both exams will be fused using the fiducials. The Clinical Target Volume (CTV) will include systematically the coeliac trunk until the aorta with a margin of at least 1 cm, the origin of the upper mesenteric vessels until the aorta with at least a margin of 1 cm, the space between the Inferior Cava Vein (ICV) and the aorta in front of the pancreatic region, the space between the portal vein and ICV and finally the right lateral border of the ICV in front of the pancreatic region in case of pancreatic head tumors only. The CTV will also include the tumor mass with a 1 cm margin and the locally positive CT scan or PET scanner nodes with a margin of 1 cm provided it does not overlay the digestive structures that will remain after the surgical resection. Finally all these regions will be linked to make a unique CTV structure. The PTV will be defined as an expansion of 5 mm from the CTV. The doses tolerated to the organs at risk figure in the Ongoing Study 3.
Radiation treatment will be initiated 4 weeks after the third chemotherapy cycle.
- Surgery : Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location. The extension degree of the resection will remain at the discretion of the surgeon. However all the bowel and duodenum irradiated at the prescription dose will be systematically removed whatever the importance of the surgical resection.
Minimal Follow up :
- Clinical exam every 3 months for 3 years
- Thoraco-abdominal CT scan at 6, 12, 18, 24, 30 and 36months
- PET Scanner at 6, 12, 18, 24, 30 and 36months
- CA 19.9 every 3 months for 3 years
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 | Drug: Chemotherapy, Radiation: Stereotactic radiotherapy, Procedure: SurgeryStereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Biopsy proven pancreatic adenocarcinoma
- Borderline resectable pancreatic adenocarcinoma (NCCN guidelines)
- OMS status ≤2
- Age at presentation >18 y
- Absolute neutrophil counts >1500/ml
Key exclusion criteria (14 listed)
- Distant metastases
- Evolutive disease after the neoadjuvant chemotherapy course according RECIST criteria
- Neuroendocrine tumors
- Peritoneal dissemination visualized at diagnostic abdominal CT scan
- Pathologic abdominal nodes visualized at diagnostic abdominal CT scan outside the pancreatic area
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 |
|---|---|---|
| Chemotherapy3 cycles of Gemzar-Abraxane | Drug | Stereotactic radiotherapy |
| Stereotactic radiotherapyStereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days | Radiation | Stereotactic radiotherapy |
| SurgeryWhipple procedure will be the recommended procedure but will be modified according to the initial tumor location | Procedure or surgery | Stereotactic radiotherapy |
Primary outcome
patient overall survival
Time frame: follow up during 3 years after patient inclusion
patient overall survival
4 secondary outcomes
positive surgical margins
Time frame: follow up during 3 years after patient inclusion
toxicity according the CTCAEv4
Time frame: follow up during 3 years after patient inclusion
CA19.9 level post operatively
Time frame: follow up during 3 years after patient inclusion
CEA level post operatively at one month
Time frame: follow up during 1 month after patient inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chemotherapy, Stereotactic radiotherapy and Surgery in people with Pancreatic Neoplasms, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
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 14 inclusion and 14 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: withdrawn, as of the sponsor's last update on 23 Jun 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 Luxembourg. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
patient overall survival (time frame: follow up during 3 years after patient inclusion). 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 23 Jun 2022.