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
• Interventions: Procedure: video fluoroscopy; Other: scoring acute toxicity; Procedure: extra imaging; Other: scoring quality of life (QOL); Other: scoring of late toxicity

• 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

Arm && Interventions

Group	Intervention	Description
standard radiotherapy treatment	video fluoroscopy	These patients receive the normal standard treatment.
standard radiotherapy treatment	scoring acute toxicity	These patients receive the normal standard treatment.
standard radiotherapy treatment	scoring quality of life (QOL)	These patients receive the normal standard treatment.
adaptive radiotherapy	scoring quality of life (QOL)	These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
adaptive radiotherapy	video fluoroscopy	These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
adaptive radiotherapy	extra imaging	These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
adaptive radiotherapy	scoring acute toxicity	These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
adaptive radiotherapy	scoring of late toxicity	These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
standard radiotherapy treatment	scoring of late toxicity	These patients receive the normal standard treatment.

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