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

Primary Non-operated Squamous Cell Carcinoma of Hypopharynx Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287390
• Other study ID #: 2011/012
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2011
• Last updated: January 26, 2016
• Start date: October 2011
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Oropharyngeal Neoplasms
• Primary Non-operated Squamous Cell Carcinoma of Hypopharynx
• Primary Non-operated Squamous Cell Carcinoma of Larynx
• Primary Non-operated Squamous Cell Carcinoma of Oral Cavity
• Primary Non-operated Squamous Cell Carcinoma of Oropharynx

Intervention

Procedure:
• video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
• 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.
• scoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
• 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).

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after 1 year	No
Secondary	acute treatment-induced toxicity		weekly during treatment	No
Secondary	late treatment-induced toxicity		after 1, 3, 6, 9 and 12 months	No
Secondary	tumor response: imaging		after 3 months	No
Secondary	tumor response: clinical examination		after 1, 3, 6, 9 and 12 months	No
Secondary	local, regional and distant control: imaging		after 3 months	No
Secondary	local, regional and distant control: clinical examination		after 1,3, 6, 9 and 12 months	No
Secondary	local, regional and distant control: biopsy		from 3 months on	No

External Links

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