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

January 26, 2016 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Leuven, Belgium, 3000
        • University Hospital Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of acute and late treatment-induced dysphagia
Time Frame: after 1 year
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
after 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
acute treatment-induced toxicity
Time Frame: weekly during treatment
weekly during treatment
late treatment-induced toxicity
Time Frame: after 1, 3, 6, 9 and 12 months
after 1, 3, 6, 9 and 12 months
tumor response: imaging
Time Frame: after 3 months
after 3 months
tumor response: clinical examination
Time Frame: after 1, 3, 6, 9 and 12 months
after 1, 3, 6, 9 and 12 months
local, regional and distant control: imaging
Time Frame: after 3 months
after 3 months
local, regional and distant control: clinical examination
Time Frame: after 1,3, 6, 9 and 12 months
after 1,3, 6, 9 and 12 months
local, regional and distant control: biopsy
Time Frame: from 3 months on
from 3 months on

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Wilfried De Neve, PhD, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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