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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
video fluoroscopy
extra imaging
scoring acute toxicity
scoring of late toxicity
scoring quality of life (QOL)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Non-operated Squamous Cell Carcinoma of Oral Cavity focused on measuring squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent
  • University Hospital Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard radiotherapy treatment

adaptive radiotherapy

Arm Description

These patients receive the normal standard treatment.

These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.

Outcomes

Primary Outcome Measures

Reduction of acute and late treatment-induced dysphagia
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
late treatment-induced toxicity
tumor response: imaging
tumor response: clinical examination
local, regional and distant control: imaging
local, regional and distant control: clinical examination
local, regional and distant control: biopsy

Full Information

First Posted
January 26, 2011
Last Updated
January 26, 2016
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01287390
Brief Title
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard radiotherapy treatment
Arm Type
Active Comparator
Arm Description
These patients receive the normal standard treatment.
Arm Title
adaptive radiotherapy
Arm Type
Experimental
Arm Description
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
Intervention Type
Procedure
Intervention Name(s)
video fluoroscopy
Intervention Description
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
Intervention Type
Procedure
Intervention Name(s)
extra imaging
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
scoring acute toxicity
Intervention Description
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
Intervention Type
Other
Intervention Name(s)
scoring of late toxicity
Intervention Description
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
Intervention Type
Other
Intervention Name(s)
scoring quality of life (QOL)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction of acute and late treatment-induced dysphagia
Description
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
Time Frame
after 1 year
Secondary Outcome Measure Information:
Title
acute treatment-induced toxicity
Time Frame
weekly during treatment
Title
late treatment-induced toxicity
Time Frame
after 1, 3, 6, 9 and 12 months
Title
tumor response: imaging
Time Frame
after 3 months
Title
tumor response: clinical examination
Time Frame
after 1, 3, 6, 9 and 12 months
Title
local, regional and distant control: imaging
Time Frame
after 3 months
Title
local, regional and distant control: clinical examination
Time Frame
after 1,3, 6, 9 and 12 months
Title
local, regional and distant control: biopsy
Time Frame
from 3 months on

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Neve, PhD, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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

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