Clinical trial NCT01287390: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction of acute and late treatment-induced dysphagia
timeFrame: after 1 year
Secondary outcomes:
measure: acute treatment-induced toxicity
timeFrame: weekly during treatment
measure: late treatment-induced toxicity
timeFrame: after 1, 3, 6, 9 and 12 months
measure: tumor response: imaging
timeFrame: after 3 months
measure: tumor response: clinical examination
timeFrame: after 1, 3, 6, 9 and 12 months
measure: local, regional and distant control: imaging
timeFrame: after 3 months
measure: local, regional and distant control: clinical examination
timeFrame: after 1,3, 6, 9 and 12 months
measure: local, regional and distant control: biopsy
timeFrame: from 3 months on
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: