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2017-04-20
2021-03-19
2021-03-19
0
NCT03199144
Centre Francois Baclesse, Luxembourg
Centre Francois Baclesse, Luxembourg
INTERVENTIONAL
Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer
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.
1. 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. 2. 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 ȬYM 6 Spinal CFB1" which was approved by the ⋎ntre 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. 4. 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 : 1. Clinical exam every 3 months for 3 years 2. Thoraco-abdominal CT scan at 6, 12, 18, 24, 30 and 36months 3. PET Scanner at 6, 12, 18, 24, 30 and 36months 4. CA 19.9 every 3 months for 3 years
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-06-20 | N/A | 2022-06-20 |
2017-06-22 | N/A | 2022-06-23 |
2017-06-26 | N/A | 2022-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Stereotactic radiotherapy Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days | DRUG: Chemotherapy
RADIATION: Stereotactic radiotherapy
PROCEDURE: Surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| patient overall survival | patient overall survival | follow up during 3 years after patient inclusion |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| positive surgical margins | assessment of R1 margin defined according to the British Royal College of pathology | follow up during 3 years after patient inclusion |
| toxicity according the CTCAEv4 | toxicity according the CTCAEv4 | follow up during 3 years after patient inclusion |
| CA19.9 level post operatively | CA19.9 levels post operatively | follow up during 3 years after patient inclusion |
| CEA level post operatively at one month | CEA level post operatively at one month | follow up during 1 month after patient inclusion |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
