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Head and Neck CancerRIDPAINTNCT02921581

ReIrradiation With FDG-PET Guided Dose Painting

A study testing FDG-PET guided dose painting in people with Head and Neck Cancer, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also apply for recurrent and second primary head and neck cancers in previously irradiated volumes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
FDG-PET guided dose painting
Type of treatment
Surgery or procedure
How many people
10 participants
Where
1 siteNorway
Study dates
Jun 2015to Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C02.0 - C02.9; C03.0 - C03.9; C04.0 - C04.9; C05.0 - C05.9; C06.0 - C06.9; C09.0 - C09.9; C10.0 - C10.9; C11.0 - C11.9; C12; C13.0 - C13.9; C14.0 - C14.9; C30; C31.0 - C31.9; C32.0 - C32.9
  • Planned treatment at the Norwegian Radium Hospital or at other participating university hospitals
  • Age ≥18 years
  • Ability to understand and respond to the questionnaires
  • Informed consent received
  • Squamous cell carcinoma in the head and neck region of patients previously irradiated for head and neck cancer
Show all 9Show fewer
  • No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy
  • Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer
  • ECOG performance status ≤ 2

Who cannot join

  • Patients planned for standard curative treatment (radical RT +/-concomitant chemotherapy or postoperative RT of primary disease)
  • Patients who previously have been re-irradiated for overlapping second primary or relapse
  • Other second primary tumors that are not under control
  • Distant metastatic disease

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, N-0424

Other trials in Norway

About this study

Official title: ReIrradiation With FDG-PET Guided Dose Painting for Recurrent and Second Primary Head and Neck Cancer

Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also apply for recurrent and second primary head and neck cancers in previously irradiated volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy using IMRT dose-painting by contours for patients with recurrent and second primary head and neck cancer.

Read the detailed description

The standard re-irradiation regimen for head and neck cancer patients treated at the Oslo University Hospital is 1.5 Gy twice daily during 4 weeks with a total dose of 60 Gy.

In this study the radiotherapy is planned using 18F-FDG PET/CT making one experimental "dose-painting by contours" SIB (simultaneous integrated boost) plan with a maximum point dose of 75 Gy. The participants will be given 65 Gy and 70 Gy minimum doses to two GTVs inside the conventional GTV (60 Gy). GTV_65Gy and GTV_70Gy are determined from the SUV 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 60 Gy). In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT 6 months after inclusion (4 1/2 months after end of radiotherapy) and HRQL measurements.

Being tested
FDG-PET guided dose painting
Keywords
Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDG-PET guided dose paintingRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer.

    Measured: 1 month

Secondary outcomes (2)

  1. Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST).

    Measured: 6 months

  2. Number of participants with adverse events.

    Number of participants with toxicity using CTCAE v3.0.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2020
  4. Study completionAug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02921581
Sponsor's protocol ID
2015/118
Acronym
RIDPAINT
Status last verified
Dec 2024
First submitted
27 Sep 2016
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Skjotskift T, Evensen ME, Furre T, Moan JM, Amdal CD, Bogsrud TV, Malinen E, Dale E. Dose painting for re-irradiation of head and neck cancer. Acta Oncol. 2018 Dec;57(12):1693-1699. doi: 10.1080/0284186X.2018.1512753. Epub 2018 Oct 3.

    PubMed 30280623

  • Dale E, Evensen ME, Amdal CD, Furre T, Moan JM, Heggebo LC, Londalen AM, Malinen E. Clinical outcomes after reirradiation with dose painting of recurrent or second primary head and neck cancer. Front Oncol. 2026 Sep 30;16:1966123. doi: 10.3389/fonc.2026.1966123. eCollection 2026.

    PubMed 42876552

Questions about this trial

What is this clinical trial studying?

A study testing FDG-PET guided dose painting in people with Head and Neck Cancer, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer. (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02921581, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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