The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome

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Brief Title

The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome

Official Title

The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome

Brief Summary

      Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline
      resectable disease may benefit from preoperative radiochemotherapy. However, only a subset of
      patients will respond to this potentially toxic and expensive treatment. Therefore, novel
      predictive markers are needed to determine treatment efficacy at an early stage. Preferably,
      these markers could be determined non-invasively and provide insight into the biology of
      pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment is
      often characterized by large amounts of stroma, hypovascularization, and hypoxia. As these
      three factors can all contribute to treatment resistance, a quantitative assessment of these
      markers may aid in the prediction of response to preoperative radiochemotherapy. Moreover,
      these assessments may have prognostic value. Finally, further insight into the interrelation
      of these aspects of the tumor microenvironment can contribute to the evaluation of new
      targeted treatment options. Tumor cellularity and extracellular matrix composition can be
      assessed non-invasively in vivo by diffusion weighted magnetic resonance imaging (DWI) and
      tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging
      (DCE-MRI). Finally, tumor hypoxia can be evaluated by T2* MRI and PET-CT, using the
      18F-labeled hypoxic marker HX4.

      Objective of the study:

      The primary aim of the study is to assess whether DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT
      predict overall survival in patients with pancreatic cancer treated with surgery and adjuvant
      chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.
      Secondary aims of the study include the assessment of the predictive value of DWI, DCE-MRI,
      T2*, and 18F-HX4-PET/CT for pathological response to neoadjuvant chemoradiation, the
      correlation of DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT with histopathological assessment of
      tumor stroma, vascularization, and hypoxia, and the assessment of the predictive value of
      these histopathological markers for overall survival.
    

Detailed Description

      Background of the study:

      Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline
      resectable disease may benefit from preoperative radiochemotherapy. However, only a subset of
      patients will respond to this potentially toxic and expensive treatment. Therefore, novel
      predictive markers are needed to determine treatment efficacy at an early stage. Preferably,
      these markers could be determined non-invasively and provide insight into the biology of
      pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment is
      often characterized by large amounts of stroma, hypovascularization, and hypoxia. As these
      three factors can all contribute to treatment resistance, a quantitative assessment of these
      markers may aid in the prediction of response to preoperative radiochemotherapy. Moreover,
      these assessments may have prognostic value. Finally, further insight into the interrelation
      of these aspects of the tumor microenvironment can contribute to the evaluation of new
      targeted treatment options. Tumor cellularity and extracellular matrix composition can be
      assessed non-invasively in vivo by diffusion weighted magnetic resonance imaging (DWI) and
      tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging
      (DCE-MRI). Finally, tumor hypoxia can be evaluated by T2* MRI and PET-CT, using the
      18F-labeled hypoxic marker HX4.

      Objective of the study:

      The primary aim of the study is to assess whether DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT
      predict overall survival in patients with pancreatic cancer treated with surgery and adjuvant
      chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.
      Secondary aims of the study include the assessment of the predictive value of DWI, DCE-MRI,
      T2*, and 18F-HX4-PET/CT for pathological response to neoadjuvant chemoradiation, the
      correlation of DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT with histopathological assessment of
      tumor stroma, vascularization, and hypoxia, and the assessment of the predictive value of
      these histopathological markers for overall survival.

      Study design:

      The target population will be recruited from the the Academic Medical Centre (AMC) and
      Erasmus MC. First, to assess reproducibility, patients with pancreatic cancer will undergo
      MRI twice, once in the AMC and once in the EMC. Next, 40 consecutive patients that will
      undergo surgery+adjuvant treatment will have MRI and 18F-HX4-PET/CT measurements once to
      assess the value of the techniques to predict outcome of standard treatment. 40 patients who
      will undergo preoperative radiochemotherapy will have MRI and 18F-HX4-PET/CT at baseline, and
      1 week before surgery. We will assess the relative contribution of each imaging method as
      well as the integrated use of these methods as predictive markers for survival and
      pathological response to treatment. Tumor tissue from resected patients will be analyzed for
      markers of tumor vascularization (CD31, VEGF), hypoxia (HIF1alfa, GLUT1, CA9), and stromal
      activation (smooth muscle actin, markers for Hedgehog pathway activity). Results will be
      correlated with imaging parameters, as well as patient outcome.
    


Study Type

Interventional


Primary Outcome

Predictive value of pretreatment DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT on overall survival in patients with pancreatic cancer treated with surgery and adjuvant chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.

Secondary Outcome

 Predictive value of pretreatment DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT on recurrence free survival in patients with pancreatic cancer treated with surgery and adjuvant chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.

Condition

Pancreatic Cancer

Intervention

Gadobutrol

Study Arms / Comparison Groups

 Neoadjuvant radiochemotherapy
Description:  Patients elected for neoadjuvant radiochemotherapy undergo DWI-MRI, DCE-MRI (Gadobutrol),T2*-MRI and [F-18]HX4 PET/CT imaging within two weeks before start of the chemoradiation and again after radiochemotherapy (Gemcitabine/Radiotherapy), within two weeks before surgery (Pancreaticoduodenectomy).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

47

Start Date

November 2013

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with pancreatic tumors, with histological or cytological proof of
             adenocarcinoma or a high suspicion on CT imaging.

          -  Tumor size ≥ 1cm.

          -  WHO-performance score 0-2.

          -  Scheduled for surgery or neo-adjuvant chemotherapy/radiation followed by surgery. For
             the reproducibility part of the study, patients who will not undergo surgery, may be
             included, too.

          -  Written informed consent.

        Exclusion Criteria:

          -  Any psychological, familial, sociological or geographical condition potentially
             hampering adequate informed consent or compliance with the study protocol.

          -  Contra-indications for MR scanning, including patients with a pacemaker, cochlear
             implant or neurostimulator; patients with non-MR compatible metallic implants in their
             eye, spine, thorax or abdomen; or a non-MR compatible aneurysm clip in their brain;
             patients with severe claustrophobia.

          -  Renal failure (GFR < 30 ml/min) hampering safe administration of Gadolinium containing
             MR contrast agent.

          -  For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy
             foreseen within the timeframe needed for MR scanning.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT01989000

Organization ID

NL45913.018.13


Responsible Party

Principal Investigator

Study Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

 Erasmus Medical Center

Study Sponsor

, , 


Verification Date

June 2018