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Prediction of Outcome After Chemoradiotherapy for Head and Neck Cancer Using Functional Imaging and Tumor Biology

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ClinicalTrials.gov Identifier: NCT01829646
Recruitment Status : Unknown
Verified April 2013 by Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : April 11, 2013
Last Update Posted : April 16, 2013
Sponsor:
Collaborator:
Flemish League Against Cancer
Information provided by (Responsible Party):
Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven

Brief Summary:
Despite uniform histopathological definition the response of locally advanced squamous cell carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with locoregional recurrences burdening this patient population. The addition of concurrent chemotherapy and the use of altered fractionation schedules has significantly increased locoregional control and overall survival over the last decade however, this has come at the cost of increased acute and late toxicity, preventing further treatment intensification in all patients. If the investigators want to increase the therapeutic index of HNSCC, we need to be able to tailor the treatment more individually to each patient. The project aims at developing a prognostic model for head and neck cancer patients based on the combination of known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging (MRI) obtained before and during treatment. The investigators plan a prospective trial where 120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will be included. Prior to treatment biopsy material will be collected for genetic analysis and before and during treatment functional MRI with diffusion weighted and dynamic contrast enhanced imaging will be performed. All patients will be followed up multidisciplinary afterwards with follow-up of tumor status and toxicity.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: functional MRI Other: Hypoxia gene expression profile. Other: Functional MRI before start of treatment. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Prediction of Outcome After Chemoradiotherapy for Head and Neck Cancer Using Functional Imaging and Tumor Biology. A Prospective, Non-commercial and Mono-centric Study.
Study Start Date : March 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: functional MRI
    Functional MRI on day 22 of the chemoradiotherapy treatment. Parameters of these images will be later on correlated with outcome.
  • Other: Hypoxia gene expression profile.
    Tumour biopsies will be obtained as part of the staging procedure (standard). On this biopsies we will conduct a hypoxia gene expression profile (15 genes on PCR that can be analyzed individually or as a group through one binary variable). Hypoxia will be a parameter in our prognostic/predictive model.
  • Other: Functional MRI before start of treatment.
    As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with outcome.


Primary Outcome Measures :
  1. To correlate clinical, molecular and radiological predictors with outcome, as defined by locoregional control and disease free survival. In this way we will develop a prognostic/predictive model. [ Time Frame: 4 year time period ]
    The predictive model will be instrumental in the individualization of treatment ensuring optimized treatment and avoiding under- and overtreatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • Patients with non-metastatic locally advanced oropharyngeal cancer who will be treated with chemoradiotherapy, as decided after multidisciplinary consultation.
  • A karnofsky performance status ≥ 70%
  • Gender: Male - Female
  • Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  • Prior irradiation to the head and neck region
  • Medical contraindications for any of the planned investigations
  • Distant metastases
  • Pregnant or lactating women
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
  • Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

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): NCT01829646


Contacts
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Contact: Daan Nevens, MD 0032473583893 daan.nevens@uzleuven.be

Locations
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Belgium
Departement of Radiation Oncology Recruiting
Leuven, Belgium, 3000
Contact: Daan Nevens, MD    016440110    daan.nevens@uzleuven.be   
Sub-Investigator: Daan Nevens, MD         
Principal Investigator: Sandra Nuyts, PhD, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Flemish League Against Cancer
Investigators
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Principal Investigator: Sandra Nuyts, PhD, MD Universitaire Ziekenhuizen Leuven
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Responsible Party: Dr. Sandra Nuyts, Full Professor, Clinical staff member, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01829646    
Other Study ID Numbers: S54731
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013
Keywords provided by Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven:
DWI
DCE MRI
ADC
FDG PET
Hypoxia
Prognostic and predictive model
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms