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Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer (CKPancreas)

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ClinicalTrials.gov Identifier: NCT03199144
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse, Luxembourg

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: Chemotherapy Radiation: Stereotactic radiotherapy Procedure: Surgery Phase 2

Detailed Description:

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 "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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Borderline Resectable Pancreatic Cancer : Phase II Study
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stereotactic radiotherapy
Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days
Drug: Chemotherapy
3 cycles of Gemzar-Abraxane

Radiation: Stereotactic radiotherapy
Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days

Procedure: Surgery
Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location




Primary Outcome Measures :
  1. patient overall survival [ Time Frame: follow up during 3 years after patient inclusion ]
    patient overall survival


Secondary Outcome Measures :
  1. positive surgical margins [ Time Frame: follow up during 3 years after patient inclusion ]
    assessment of R1 margin defined according to the British Royal College of pathology

  2. toxicity according the CTCAEv4 [ Time Frame: follow up during 3 years after patient inclusion ]
    toxicity according the CTCAEv4

  3. CA19.9 level post operatively [ Time Frame: follow up during 3 years after patient inclusion ]
    CA19.9 levels post operatively

  4. CEA level post operatively at one month [ Time Frame: follow up during 1 month after patient inclusion ]
    CEA level post operatively at one month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199144


Contacts
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Contact: Philippe Nickers, MD, PHD 00352571167200 philippe.nickers@baclesse.lu
Contact: Charlotte Lieunard 00352571167200 charlotte.lieunard@baclesse.lu

Locations
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Luxembourg
Centre Francois Baclesse Recruiting
Esch-sur-Alzette, SUD, Luxembourg, L-4240
Contact: Philippe Nickers, MD, PHD    00352571167200    philippe.nickers@baclesse.lu   
Contact: Charlotte Lieunard    00352571167200    charlotte.lieunard@baclesse.lu   
Sponsors and Collaborators
Centre Francois Baclesse, Luxembourg

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Responsible Party: Centre Francois Baclesse, Luxembourg
ClinicalTrials.gov Identifier: NCT03199144     History of Changes
Other Study ID Numbers: Pancreas cancer neoadjuvant
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse, Luxembourg:
Pancreatic Neoplasms
Borderline resectable
Neoadjuvant treatment
Chemotherapy
Stereotactic radiation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases