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Trial Title:
RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3
NCT ID:
NCT06297902
Condition:
Head and Neck Cancer
Radiotherapy Side Effect
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
Dose painting
18F-FDG
Positron emission tomography
Radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Phase 2
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Dose painting
Description:
Dose painting
Arm group label:
Dose painting
Summary:
The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe
compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority,
multi-center phase II study, initiated at the Section for Head and Neck Cancer,
Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The
primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after
treatment. The expected inclusion period is three years, total study duration is six
years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s
Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either
standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose
painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose
positron emission computed tomography (FDG-PET/CT) prior to radiotherapy. In the
experimental arm, we will escalate the dose to the hypermetabolic part of the tumor
(maximum point dose 83.3 Gy), shown in pre-treatment FDG-PET images. Dose escalation will
be applied to these regions during the first half of the fractionated treatment (17 of 34
fractions). The patients in both arms will receive concomitant nimorazole (hypoxic
radiosensitizer) and concomitant cisplatin if indicated according to standard treatment.
The main inclusion criterion is patients with human-papillomavirus (HPV)-unrelated head
and neck cancer with poor prognosis.
The RADPAINT-3 trial includes a translational sub-study where we aim to elucidate
underlying mechanisms related to the radiotherapy effect, by investigating blood samples.
Analysis of cytokines in repetitive blood samples may predict both tumor response and
toxicity. The data derived from this sub-study, will be further explored using artificial
intelligence.
If RADPAINT-3 shows that there is no excess toxicity, we will continue the study after a
new protocol has been approved. The new primary endpoint will be local control at 1 year
after radiotherapy. Power analysis show that we will need in total 182 evaluable patients
including the 100 patients from RADPAINT-3. The translational sub-study will then be
extended to investigate genetic expression data from pre-therapy routine tumor biopsies
and correlate this with the analysis of blood samples and tumor control.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically or cytologically verified invasive squamous cell carcinoma of the
head and neck region; Sinonasal cancer, oral cavity cancer, hypopharynx cancer,
larynx cancer, HPV negative oropharyngeal cancer and T4 (any N) HPV positive
oropharyngeal cancer.
2. Patients planned for standard curative RT (with or without concomitant chemotherapy
[cisplatin, or cetuximab], with or without nimorazole hypoxic cell radiosensitizer)
3. Age > 18 years
4. WHO performance status 0-2
5. Signed informed consent
6. Ability to understand information about the study and to complete questionnaires
Exclusion Criteria:
1. All diagnoses, cT1 cN0-N1 cM0
2. Glottic cancer cT1-T2 cN0 cM0
3. HPV positive oropharyngeal carcinoma T1-T3 (any N)
4. Diabetes mellitus
5. Use of anticoagulant medication
6. Active smoking and/or alcohol abuse
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Einar Dale, PhD
Phone:
+4722934000
Email:
eindal@ous-hf.no
Start date:
August 19, 2024
Completion date:
June 2030
Lead sponsor:
Agency:
Oslo University Hospital
Agency class:
Other
Collaborator:
Agency:
Haukeland University Hospital
Agency class:
Other
Collaborator:
Agency:
St. Olavs Hospital
Agency class:
Other
Collaborator:
Agency:
Norwegian University of Life Sciences
Agency class:
Other
Source:
Oslo University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06297902
