A Phase 2 interventional study of Chemotherapy and Stereotactic radiotherapy in Pancreatic Neoplasms, sponsored by Centre Francois Baclesse, Luxembourg. Withdrawn at 1 site in Luxembourg. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Centre Francois Baclesse, Luxembourg · Phase 2, Interventional, and Treatment
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.
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.
Minimal Follow up :
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
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Exclusion Criteria:
Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days
Drug: Chemotherapy · Radiation: Stereotactic radiotherapy · Procedure: Surgery
3 cycles of Gemzar-Abraxane
Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days
Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location
patient overall survival
patient overall survival
Time frame: follow up during 3 years after patient inclusion
positive surgical margins
assessment of R1 margin defined according to the British Royal College of pathology
Time frame: follow up during 3 years after patient inclusion
toxicity according the CTCAEv4
toxicity according the CTCAEv4
Time frame: follow up during 3 years after patient inclusion
CA19.9 level post operatively
CA19.9 levels post operatively
Time frame: follow up during 3 years after patient inclusion
CEA level post operatively at one month
CEA level post operatively at one month
Time frame: follow up during 1 month after patient inclusion
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Centre Francois Baclesse, Luxembourg