ReIrradiation with FDG-PET Guided Dose Painting (RIDPAINT)

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: FDG-PET guided dose painting

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, N-0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST).		6 months
Number of participants with adverse events.	Number of participants with toxicity using CTCAE v3.0.	3 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian Cancer Society
• Investigators: Principal Investigator: Einar Dale, MD PhD, Oslo University Hospital

Publications and helpful links

General 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.

Helpful Links

• Regional ethics committee

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimated): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Positron emission tomography; Dose painting; 18F-FDG
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2015/118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED