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NCT03847480 Clinical Trial

Dose Painting of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— RADPAINT  

Official title:
Dose Painting of Head and Neck Cancer - The RADPAINT Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03847480
Other study ID # 2017/398
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
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 volumetric-arc radiotherapy (VMAT) for head and neck cancer. This trial (RADPAINT) investigates the safety of FDG-PET guided radiotherapy using VMAT dose-painting by contours for patients with head and neck cancer of poor prognosis.

Description:

In this study, radiotherapy is planned using 18F-FDG PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography) making one experimental "dose-painting by contours" SIB (simultaneous integrated boost) plan with a maximum point dose of 83 Gy. The participants will be given 73 Gy and 78 Gy minimum doses to two GTVs (gross tumor volumes inside the conventional GTV (68 Gy). GTV_73Gy and GTV_78Gy are determined from the SUV (standardized uptake 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 68 Gy). In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT (3 months after treatment and toxicity scoring at 6 weeks, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date December 2024
Est. primary completion date March 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Oral cavity, hypopharynx cancer, larynx cancer and HPV ((human papillomavirus) negative oropharyngeal cancer. Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer) Planned treatment at the Oslo University Hospital Age > 18 years WHO (World Health Organization) performance status 0-2 Exclusion Criteria: TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0 Glottic cancer cT1-T2 cN0 cM0 HPV positive oropharyngeal carcinoma Cancer in the soft palate Diabetes mellitus

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• FDG-PET guided dose painting
The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Late toxicity - mucosal ulcer The study will be stopped if = 2 patients experience mucosal ulcers grade = 3 (CTCAE v 3.0/v4.0) without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination. 1 year
Primary Acute or late toxicity Any life-threatening toxicity (CTCAE v4.0) related to radiotherapy. This endpoint will be assessed by clinical examination. 1 year
Secondary Acute toxicity CTCAE v4.0 < 3 months after radiotherapy
Secondary Late toxicity CTCAE v4.0 1 year
Secondary Loco-regional control FDG PET/CT at 3 months. Imaging thereafter if clinical progression. 3 years
Secondary Disease free survival FDG PET/CT at 3 months. Imaging thereafter if clinical progression. 3 years
Secondary Overall survival Date from central registry. 3 years
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