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Dose Painting of Head and Neck Cancer (RADPAINT)

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ClinicalTrials.gov Identifier: NCT03847480
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Einar Dale, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: FDG-PET guided dose painting Not Applicable

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Painting of Head and Neck Cancer - The RADPAINT Pilot Study
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Late toxicity - mucosal ulcer [ Time Frame: 1 year ]
    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.

  2. Acute or late toxicity [ Time Frame: 1 year ]
    Any life-threatening toxicity (CTCAE v4.0) related to radiotherapy. This endpoint will be assessed by clinical examination.


Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: < 3 months after radiotherapy ]
    CTCAE v4.0

  2. Late toxicity [ Time Frame: 1 year ]
    CTCAE v4.0

  3. Loco-regional control [ Time Frame: 3 years ]
    FDG PET/CT at 3 months. Imaging thereafter if clinical progression.

  4. Disease free survival [ Time Frame: 3 years ]
    FDG PET/CT at 3 months. Imaging thereafter if clinical progression.

  5. Overall survival [ Time Frame: 3 years ]
    Date from central registry.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847480


Contacts
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Contact: Einar Dale, MD PhD +4722934000 eindal@ous-hf.no
Contact: Cecilie Amdal, MD PhD +4722934000 cecia@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Sub-Investigator: Torbjørn Furre, MSc         
Sub-Investigator: Morten E Evensen, BSc         
Sub-Investigator: Eirik Malinen, PhD         
Sub-Investigator: Ayca M Løndalen, MD PhD         
Sub-Investigator: Lars TG Mikalsen, PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Director: Stein Kaasa, MD PhD Oslo University Hospital

Additional Information:
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Responsible Party: Einar Dale, Senior Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03847480     History of Changes
Other Study ID Numbers: 2017/398
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Einar Dale, Oslo University Hospital:
Dose painting
18F-FDG
Positron emission tomography
Radiotherapy

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms