Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ReIrradiation With FDG-PET Guided Dose Painting (RIDPAINT)

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: NCT02921581
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Norwegian Cancer Society
Information provided by (Responsible Party):
Einar Dale, Oslo University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ReIrradiation With FDG-PET Guided Dose Painting for Recurrent and Second Primary Head and Neck Cancer
Actual Study Start Date : June 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST). [ Time Frame: 6 months ]
  2. Number of participants with adverse events. [ Time Frame: 3 years ]
    Number of participants with toxicity using CTCAE v3.0.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02921581


Contacts
Layout table for location contacts
Contact: Einar Dale, MD PhD eindal@ous-hf.no

Locations
Layout table for location information
Norway
Oslo University Hospital Recruiting
Oslo, Norway, N-0424
Contact: Einar Dale, PhD MD       eindal@ous-hf.no   
Sub-Investigator: Cecilie D Amdal, MD PhD         
Sub-Investigator: Kristin Bjordal, MD PhD         
Sub-Investigator: Jon M Moan, MD         
Sub-Investigator: Morten E Evensen, BSc         
Sub-Investigator: Torbjørn Furre, MSc         
Sub-Investigator: Eirik Malinen, MSc PhD         
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
Investigators
Layout table for investigator information
Principal Investigator: Einar Dale, MD PhD Oslo University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Regional ethics committee  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Einar Dale, Senior Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02921581     History of Changes
Other Study ID Numbers: 2015/118
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms