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

December 13, 2022 updated by: University Hospital, Ghent

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Department of Radiotherapy, University Hospital Ghent
      • Namur, Belgium
        • Clinique & Materinité Sainte Elisabeth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional (elective neck) and distant control.
Time Frame: after 1 year
18F-FDG-PET/CT scans will be performed.
after 1 year
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
during the first year post-treatment
Tumor response
Time Frame: 3 months post-treatment
18F-FDG-PET/CT scans will be performed
3 months post-treatment
Acute toxicity
Time Frame: up to 12 months of follow-up
up to 12 months of follow-up
Overall disease-specific, disease-free survival.
Time Frame: at 1 year
at 1 year
Late toxicity
Time Frame: up to 12 months of follow-up
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.
during the first year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Wilfried De Neve, Ph.D., M.D., University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Actual)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Non-operated Squamous Cell Carcinoma of Oral Cavity

Clinical Trials on Adaptive dose-painting-by-numbers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe