Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01287390
First received: January 26, 2011
Last updated: May 6, 2014
Last verified: February 2013

January 26, 2011
May 6, 2014
October 2011
September 2015   (final data collection date for primary outcome measure)
Reduction of acute and late treatment-induced dysphagia [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
Same as current
Complete list of historical versions of study NCT01287390 on ClinicalTrials.gov Archive Site
  • acute treatment-induced toxicity [ Time Frame: weekly during treatment ] [ Designated as safety issue: No ]
  • late treatment-induced toxicity [ Time Frame: after 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • tumor response: imaging [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
  • tumor response: clinical examination [ Time Frame: after 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • local, regional and distant control: imaging [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
  • local, regional and distant control: clinical examination [ Time Frame: after 1,3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • local, regional and distant control: biopsy [ Time Frame: from 3 months on ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.

Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:

  • adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
  • reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Non-operated Squamous Cell Carcinoma of Oral Cavity
  • Primary Non-operated Squamous Cell Carcinoma of Oropharynx
  • Primary Non-operated Squamous Cell Carcinoma of Hypopharynx
  • Primary Non-operated Squamous Cell Carcinoma of Larynx
  • Procedure: video fluoroscopy
    video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
  • Procedure: extra imaging
    For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.
  • Other: scoring acute toxicity
    Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
  • Other: scoring of late toxicity
    Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
  • Other: scoring quality of life (QOL)
    Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).
  • Active Comparator: standard radiotherapy treatment
    These patients receive the normal standard treatment.
    Interventions:
    • Procedure: video fluoroscopy
    • Other: scoring acute toxicity
    • Other: scoring of late toxicity
    • Other: scoring quality of life (QOL)
  • Experimental: adaptive radiotherapy
    These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
    Interventions:
    • Procedure: video fluoroscopy
    • Procedure: extra imaging
    • Other: scoring acute toxicity
    • Other: scoring of late toxicity
    • Other: scoring quality of life (QOL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
  • Primary non-resected tumor and/or patients refused surgery
  • Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
  • Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
  • Karnofsky performance status >= 70 %
  • Age >= 18 years old
  • Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  • Treatment combined with brachytherapy
  • Prior irradiation to the head and neck region
  • Surgery of the primary tumor except lymph node dissection prior to radiotherapy
  • induction chemotherapy
  • 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 at least 5 years
  • Distant metastases
  • Creatinine clearance (Cockroft-Gault) =< 60 milliliter/minute before treatment or creatinine value > 1,3 milligram/deciliter
  • Known allergy to the CT-contrast agents
  • 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 protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01287390
2011/012
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Wilfried De Neve, PhD, MD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP