Back to resultsRAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck (RADPAINT-2)
Primary Purpose
Head and Neck Cancer
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
FDG-PET guided dose painting
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Sinonasal, oral cavity, hypopharynx cancer, larynx cancer, HPV-unrelated (p16 negative and/or HPV DNA negative) oropharyngeal cancer and TNM (primary tumor, regional nodes, metastasis) stage T4 any N M0 HPV-related (p16 positive and/or HPV DNA positive) oropharyngeal cancer.
Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with or without nimorazole hypoxic cell radiosensitizer) Planned treatment at the Oslo University Hospital Age > 18 years WHO (World Health Organization) performance status 0-2
Exclusion Criteria:
TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0 Glottic cancer cT1-T2 cN0 cM0 HPV-related oropharyngeal carcinoma cT1-T3 (any N) Cancer in the soft palate Diabetes mellitus Use of anticoagulant (or platelet inhibitor) Active smoking and/or alcohol abuse
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose painting
Arm Description
Dose painting
Outcomes
Primary Outcome Measures
Late toxicity - mucosal ulcer
The study will be stopped if ≥ 3 patients experience late toxicity as assessed by CTCAE v5.0; mucosal ulcers grade ≥ 3 without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination.
Acute or late toxicity
Any life-threatening toxicity (CTCAE v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination.
Secondary Outcome Measures
Acute toxicity
CTCAE v5.0
Late toxicity
CTCAE v5.0
Loco-regional control
FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
Disease free survival
FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
Overall survival
Date from central registry.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04910308
Brief Title
RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck
Acronym
RADPAINT-2
Official Title
RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in volumetric-arc radiotherapy (VMAT) for head and neck cancer. This trial (RADPAINT) investigates the safety of FDG-PET guided radiotherapy using VMAT dose-painting by contours for patients with head and neck cancer of poor prognosis.
Detailed Description
In this study, radiotherapy is planned using 18F-FDG PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography) making one experimental "dose-painting by contours" SIB (simultaneous integrated boost) plan with a maximum point dose of 83 Gy. The participants will be given 73 Gy and 78 Gy minimum doses to two GTVs (gross tumor volumes inside the conventional GTV (68 Gy). GTV_73Gy and GTV_78Gy are determined from the SUV (standardized uptake values) from the 18F-FDG PET/CT according to the formula proposed by the Ghent group (Van der Straeten et al, R&O -06). It is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 68 Gy).
In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT (3 months after treatment and toxicity scoring at 6 weeks, 3 months, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose painting
Arm Type
Experimental
Arm Description
Dose painting
Intervention Type
Radiation
Intervention Name(s)
FDG-PET guided dose painting
Intervention Description
The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.
Primary Outcome Measure Information:
Title
Late toxicity - mucosal ulcer
Description
The study will be stopped if ≥ 3 patients experience late toxicity as assessed by CTCAE v5.0; mucosal ulcers grade ≥ 3 without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination.
Time Frame
1 year
Title
Acute or late toxicity
Description
Any life-threatening toxicity (CTCAE v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acute toxicity
Description
CTCAE v5.0
Time Frame
< 3 months after radiotherapy
Title
Late toxicity
Description
CTCAE v5.0
Time Frame
1 year
Title
Loco-regional control
Description
FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
Time Frame
3 years
Title
Disease free survival
Description
FDG PET/CT at 3 months. Imaging thereafter if clinical progression.
Time Frame
3 years
Title
Overall survival
Description
Date from central registry.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Sinonasal, oral cavity, hypopharynx cancer, larynx cancer, HPV-unrelated (p16 negative and/or HPV DNA negative) oropharyngeal cancer and TNM (primary tumor, regional nodes, metastasis) stage T4 any N M0 HPV-related (p16 positive and/or HPV DNA positive) oropharyngeal cancer.
Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with or without nimorazole hypoxic cell radiosensitizer) Planned treatment at the Oslo University Hospital Age > 18 years WHO (World Health Organization) performance status 0-2
Exclusion Criteria:
TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0 Glottic cancer cT1-T2 cN0 cM0 HPV-related oropharyngeal carcinoma cT1-T3 (any N) Cancer in the soft palate Diabetes mellitus Use of anticoagulant (or platelet inhibitor) Active smoking and/or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Kaasa, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck
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