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
  Purpose

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.

Condition Intervention Phase
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
Procedure: extra imaging
Other: scoring acute toxicity
Other: scoring of late toxicity
Other: scoring quality of life (QOL)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard radiotherapy treatment
These patients receive the normal standard treatment.
Procedure: video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
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).
Experimental: adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
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).

  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 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
  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: NCT01287390

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
University Hospital Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Wilfried De Neve, PhD, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01287390     History of Changes
Other Study ID Numbers: 2011/012
Study First Received: January 26, 2011
Last Updated: May 6, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
squamous cell carcinoma
oral cavity
oropharynx
hypopharynx
larynx

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014