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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01287390

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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 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).

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

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)

Outcome Measures

Primary Outcome Measures

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

acute treatment-induced toxicity [weekly during treatment]
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]
local, regional and distant control: imaging [after 3 months]
local, regional and distant control: clinical examination [after 1,3, 6, 9 and 12 months]
local, regional and distant control: biopsy [from 3 months on]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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