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NCT02921581 Clinical Trial

ReIrradiation With FDG-PET Guided Dose Painting

Head and Neck Cancer Clinical Trial

— RIDPAINT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02921581
Other study ID # 2015/118
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2024

Study information
Verified date November 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Radiation:
• FDG-PET guided dose painting

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital Norwegian Cancer Society

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer. 1 month
Secondary Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST). 6 months
Secondary Number of participants with adverse events. Number of participants with toxicity using CTCAE v3.0. 3 years
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