Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer. (C-ART-2)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Primary Non-operated Squamous Cell Carcinoma of Larynx; Primary Non-operated Squamous Cell Carcinoma of Oral Cavity; Primary Non-operated Squamous Cell Carcinoma of Hypopharynx; Primary Non-operated Squamous Cell Carcinoma of Oropharynx

Treatments: Radiation: Adaptive dose-painting-by-numbers; Radiation: standard intensity-modulated radiotherapy (IMRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01341535

2010/567

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

adaptive DPBN

Experimental group

Description:

This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.

Treatment:

Radiation: Adaptive dose-painting-by-numbers

standard IMRT

Active Comparator group

Description:

This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.

Treatment:

Radiation: standard intensity-modulated radiotherapy (IMRT)