search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Adaptive dose-painting-by-numbers
standard intensity-modulated radiotherapy (IMRT)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Non-operated Squamous Cell Carcinoma of Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

adaptive DPBN

standard IMRT

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Regional (elective neck) and distant control.
18F-FDG-PET/CT scans will be performed.
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
Tumor response
18F-FDG-PET/CT scans will be performed
Acute toxicity
Overall disease-specific, disease-free survival.
Late toxicity
Time point of local and/or regional relapse.
18F-FDG-PET/CT scans will be performed.

Full Information

First Posted
April 11, 2011
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT01341535
Brief Title
Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Neve, Ph.D., M.D.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiotherapy, University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinique & Materinité Sainte Elisabeth
City
Namur
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs