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

Phase 2

Completed

• Conditions: Primary Non-operated Squamous Cell Carcinoma of Oral Cavity; Primary Non-operated Squamous Cell Carcinoma of Larynx; Primary Non-operated Squamous Cell Carcinoma of Oropharynx; Primary Non-operated Squamous Cell Carcinoma of Hypopharynx

• Registration Number: NCT01287390
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-01
• Study Start: 2011-10
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of acute and late treatment-induced dysphagia	after 1 year	Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

University Hospital Leuven; 🇧🇪 Leuven, Belgium