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NCT Number: NCT01341535

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Radiotherapy, University Hospital Ghent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adaptive dose-painting-by-numbers

Radiation

Adaptive dose escalation by dose-painting-by-numbers.

standard intensity-modulated radiotherapy (IMRT)

Radiation

Standard radiotherapy for head and neck cancer.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Regional (elective neck) and distant control.

    Time frame: after 1 year

    18F-FDG-PET/CT scans will be performed.

  2. 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

  3. Tumor response

    Time frame: 3 months post-treatment

    18F-FDG-PET/CT scans will be performed

  4. Acute toxicity

    Time frame: up to 12 months of follow-up

  5. Overall disease-specific, disease-free survival.

    Time frame: at 1 year

  6. Late toxicity

    Time frame: up to 12 months of follow-up

  7. Time point of local and/or regional relapse.

    Time frame: during the first year post-treatment

    18F-FDG-PET/CT scans will be performed.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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.

Acronym: C-ART-2

Important dates

Study start
2011
Primary completion
2017
Study completion
2021
First posted
Apr 25, 2011
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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