Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer. (C-ART-2)
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ClinicalTrials.gov Identifier: NCT01341535 |
Recruitment Status :
Active, not recruiting
First Posted : April 25, 2011
Last Update Posted : February 17, 2021
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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 | Radiation: Adaptive dose-painting-by-numbers Radiation: standard intensity-modulated radiotherapy (IMRT) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | September 2011 |
Actual Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: adaptive DPBN
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. |
Radiation: Adaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers. |
Active Comparator: standard IMRT
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. |
Radiation: standard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer. |
- To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. [ Time Frame: at 1 year ]18F-FDG-PET/CT scans will be performed.
- Regional (elective neck) and distant control. [ Time Frame: after 1 year ]18F-FDG-PET/CT scans will be performed.
- Topography of local and/or regional relapse. [ Time Frame: during the first year post-treatment ]18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse
- Tumor response [ Time Frame: 3 months post-treatment ]18F-FDG-PET/CT scans will be performed
- Acute toxicity [ Time Frame: up to 12 months of follow-up ]
- Overall disease-specific, disease-free survival. [ Time Frame: at 1 year ]
- Late toxicity [ Time Frame: up to 12 months of follow-up ]
- Time point of local and/or regional relapse. [ Time Frame: during the first year post-treatment ]18F-FDG-PET/CT scans will be performed.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341535
Belgium | |
Department of Radiotherapy, University Hospital Ghent | |
Ghent, Belgium, 9000 | |
Clinique & Materinité Sainte Elisabeth | |
Namur, Belgium |
Principal Investigator: | Wilfried De Neve, Ph.D., M.D. | University Hospital, Ghent |
Responsible Party: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT01341535 |
Other Study ID Numbers: |
2010/567 |
First Posted: | April 25, 2011 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |