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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01341535
First received: April 11, 2011
Last updated: December 4, 2014
Last verified: December 2014
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    18F-FDG-PET/CT scans will be performed.


Secondary Outcome Measures:
  • Regional (elective neck) and distant control. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    18F-FDG-PET/CT scans will be performed.

  • Topography of local and/or regional relapse. [ Time Frame: during the first year post-treatment ] [ Designated as safety issue: No ]
    18F-FDG-PET/CT scans will be performedduring the first year post-treatment time point of local and/or regional relapse

  • Tumor response [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
    18F-FDG-PET/CT scans will be performed

  • Acute toxicity [ Time Frame: up to 12 months of follow-up ] [ Designated as safety issue: Yes ]
  • Overall disease-specific, disease-free survival. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Late toxicity [ Time Frame: up to 12 months of follow-up ] [ Designated as safety issue: Yes ]
  • Time point of local and/or regional relapse. [ Time Frame: during the first year post-treatment ] [ Designated as safety issue: No ]
    18F-FDG-PET/CT scans will be performed.
Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01341535     History of Changes
Other Study ID Numbers: 2010/567
Study First Received: April 11, 2011
Last Updated: December 4, 2014
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on March 03, 2015