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WithdrawnNCT03199144CKPancreasUpdated Jun 23, 2022

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

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 Withdrawn at 1 site in Luxembourg.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

Why this study was withdrawn
difficulties to recruit patients
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 the 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.
  1. 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.

  1. 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
02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Pancreatic Neoplasms
  • Borderline resectable
  • Neoadjuvant treatment
  • Chemotherapy
  • Stereotactic radiation
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Centre Francois Baclesse, Luxembourg is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Stereotactic radiotherapy

    Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days

    Drug: Chemotherapy · Radiation: Stereotactic radiotherapy · Procedure: Surgery

Interventions

  • DrugChemotherapy

    3 cycles of Gemzar-Abraxane

  • RadiationStereotactic radiotherapy

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

  • ProcedureSurgery

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

06

What researchers measure

Primary outcomes

  1. patient overall survival

    patient overall survival

    Time frame: follow up during 3 years after patient inclusion

Secondary outcomes

  1. 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

  2. toxicity according the CTCAEv4

    toxicity according the CTCAEv4

    Time frame: follow up during 3 years after patient inclusion

  3. CA19.9 level post operatively

    CA19.9 levels post operatively

    Time frame: follow up during 3 years after patient inclusion

  4. CEA level post operatively at one month

    CEA level post operatively at one month

    Time frame: follow up during 1 month after patient inclusion

07

Study locations

1 site
  • Centre Francois Baclesse
    Esch-sur-Alzette, SUD L-4240, Luxembourg
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03199144
Lead sponsor
Centre Francois Baclesse, Luxembourg
Responsible party
Sponsor
First posted
Jun 26, 2017
Start date
Apr 20, 2017
Primary completion
Mar 19, 2021
Completion
Mar 19, 2021
Last update
Jun 23, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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