Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.

Primary Non-operated Squamous Cell Carcinoma of Hypopharynx Clinical Trial

— C-ART-2  

Official title:

A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341535
• Other study ID #: 2010/567
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: July 15, 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 15, 2021
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx

• Primary unresectable tumor and/or patients that refused surgery

• Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer

• Multidisciplinary decision of curative radiotherapy or radiochemotherapy

• Karnofsky performance status >= 70 %

• Age >= 18 years old

• Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

• High risk Human Papilloma Virus (HPV)

• Treatment combined with brachytherapy

• Prior irradiation to the head and neck region

• 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 for at least 5 years.

• Distant metastases

• Pregnant or lactating women

• Creatinine clearance (Cockcroft-Gault) =< 60 mL/min

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck 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
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• Adaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers.
• standard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer.

Locations

Country	Name	City	State
Belgium	Department of Radiotherapy, University Hospital Ghent	Ghent
Belgium	Clinique & Materinité Sainte Elisabeth	Namur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.	18F-FDG-PET/CT scans will be performed.	at 1 year
Secondary	Regional (elective neck) and distant control.	18F-FDG-PET/CT scans will be performed.	after 1 year
Secondary	Topography of local and/or regional relapse.	18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse	during the first year post-treatment
Secondary	Tumor response	18F-FDG-PET/CT scans will be performed	3 months post-treatment
Secondary	Acute toxicity		up to 12 months of follow-up
Secondary	Overall disease-specific, disease-free survival.		at 1 year
Secondary	Late toxicity		up to 12 months of follow-up
Secondary	Time point of local and/or regional relapse.	18F-FDG-PET/CT scans will be performed.	during the first year post-treatment

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