RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3

NCT ID: NCT06297902

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2030-06-30

Brief 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.

Conditions

Head and Neck Cancer; Radiotherapy Side Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose painting

Radiation dose will be escalated 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).

Group Type: EXPERIMENTAL

Dose painting

Intervention Type: RADIATION

Dose painting

Standard radiotherapy

Homogeneous dose to the tumor.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dose painting

Dose painting

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Einar Dale

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Einar Dale

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

St. Olavs Hospital

Trondheim, , Norway

Site Status: NOT_YET_RECRUITING

Countries

Norway

Central Contacts

Einar Dale, PhD

Role: CONTACT

eindal@ous-hf.no

+4722934000

Facility Contacts

Marianne Brydøy, PhD

Role: primary

Einar Dale, PhD

Role: primary

eindal@ous-hf.no

+4722934000

Mirjam D Alsaker, PhD

Role: primary

References

Evensen ME, Furre T, Malinen E, Londalen AM, Dale E. Mucosa-sparing dose painting of head and neck cancer. Acta Oncol. 2022 Feb;61(2):141-145. doi: 10.1080/0284186X.2021.2022200. Epub 2022 Jan 6. No abstract available.

Reference Type: BACKGROUND

PMID: 34991431 (View on PubMed)

Other Identifiers

2023_31

Identifier Type: -

Identifier Source: org_study_id