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RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck (RADPAINT-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04910308
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : July 28, 2021
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, 3 months, 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 : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose painting
Dose painting
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 ≥ 3 patients experience late toxicity as assessed by CTCAE v5.0; mucosal ulcers grade ≥ 3 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 v5.0) related to radiotherapy. This endpoint will be assessed by clinical examination.


Secondary Outcome Measures :
  1. Acute toxicity [ Time Frame: < 3 months after radiotherapy ]
    CTCAE v5.0

  2. Late toxicity [ Time Frame: 1 year ]
    CTCAE v5.0

  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.



Information from the National Library of Medicine

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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; Sinonasal, oral cavity, hypopharynx cancer, larynx cancer, HPV-unrelated (p16 negative and/or HPV DNA negative) oropharyngeal cancer and TNM (primary tumor, regional nodes, metastasis) stage T4 any N M0 HPV-related (p16 positive and/or HPV DNA positive) oropharyngeal cancer.

Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with or without 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-related oropharyngeal carcinoma cT1-T3 (any N) Cancer in the soft palate Diabetes mellitus Use of anticoagulant (or platelet inhibitor) Active smoking and/or alcohol abuse


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): NCT04910308


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

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, N-0424
Contact: Einar Dale, MD PhD    +4722934000    eindal@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Director: Stein Kaasa, MD PhD Oslo University Hospital
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Responsible Party: Einar Dale, Senior Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04910308    
Other Study ID Numbers: 252575
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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