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ReIrradiation With FDG-PET Guided Dose Painting (RIDPAINT)

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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

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer. [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02921581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST). [ Time Frame: 6 months ]
  • Number of participants with adverse events. [ Time Frame: 3 years ]
    Number of participants with toxicity using CTCAE v3.0.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ReIrradiation With FDG-PET Guided Dose Painting
Official Title  ICMJE ReIrradiation With FDG-PET Guided Dose Painting for Recurrent and Second Primary Head and Neck Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Radiation: FDG-PET guided dose painting
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2016)
20
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Einar Dale, MD PhD eindal@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02921581
Other Study ID Numbers  ICMJE 2015/118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Einar Dale, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Norwegian Cancer Society
Investigators  ICMJE
Principal Investigator: Einar Dale, MD PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP