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A Study Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01341535
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 25, 2011
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-FDG-PET/CT scans to adaptive 18F-FDG-PET-voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-FDG-PET/CT scans for head and neck cancer.

Condition or disease Intervention/treatment Phase
Primary Non-operated Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx. Radiation: Adaptive dose-painting-by-numbers Radiation: standard intensity-modulated radiotherapy (IMRT) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.
Study Start Date : September 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: adaptive dose-painting-by-numbers

This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment.

Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.

Radiation: Adaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers.
Active Comparator: standard intensity-modulated radiotherapy (IMRT)

This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers.

Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.

Radiation: standard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer.



Primary Outcome Measures :
  1. To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. [ Time Frame: at 1 year ]
    18F-FDG-PET/CT scans will be performed.


Secondary Outcome Measures :
  1. Regional (elective neck) and distant control. [ Time Frame: after 1 year ]
    18F-FDG-PET/CT scans will be performed.

  2. Topography of local and/or regional relapse. [ Time Frame: during the first year post-treatment ]
    18F-FDG-PET/CT scans will be performedduring the first year post-treatment time point of local and/or regional relapse

  3. Tumor response [ Time Frame: 3 months post-treatment ]
    18F-FDG-PET/CT scans will be performed

  4. Acute toxicity [ Time Frame: up to 12 months of follow-up ]
  5. Overall disease-specific, disease-free survival. [ Time Frame: at 1 year ]
  6. Late toxicity [ Time Frame: up to 12 months of follow-up ]
  7. Time point of local and/or regional relapse. [ Time Frame: during the first year post-treatment ]
    18F-FDG-PET/CT scans will be performed.



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

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
  • Primary unresectable tumor and/or patients that refused surgery
  • Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
  • Multidisciplinary decision of curative radiotherapy or radiochemotherapy
  • Karnofsky performance status >= 70 %
  • Age >= 18 years old
  • Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  • High risk Human Papilloma Virus (HPV)
  • Treatment combined with brachytherapy
  • Prior irradiation to the head and neck region
  • History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
  • Distant metastases
  • Pregnant or lactating women
  • Creatinine clearance (Cockcroft-Gault) =< 60 mL/min
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Patient unlikely to comply with 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): NCT01341535


Contacts
Contact: Wilfried De Neve, Ph.D., M.D. Wilfried.Deneve@ugent.be

Locations
Belgium
Department of Radiotherapy, University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Wilfried De Neve, Ph.D., M.D.       Wilfried.Deneve@ugent.be   
Principal Investigator: Wilfried De Neve, Ph.D., M.D.         
Clinique & Materinité Sainte Elisabeth Recruiting
Namen, Belgium
Contact: Jean-François Daisne, MD         
Principal Investigator: Jean-François Daisne, M.D.         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Wilfried De Neve, Ph.D., M.D. University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01341535     History of Changes
Other Study ID Numbers: 2010/567
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site