search
Back to results

ReIrradiation With FDG-PET Guided Dose Painting (RIDPAINT)

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
FDG-PET guided dose painting
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Outcomes

Primary Outcome Measures

Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer.

Secondary Outcome Measures

Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST).
Number of participants with adverse events.
Number of participants with toxicity using CTCAE v3.0.

Full Information

First Posted
September 27, 2016
Last Updated
April 29, 2022
Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT02921581
Brief Title
ReIrradiation With FDG-PET Guided Dose Painting
Acronym
RIDPAINT
Official Title
ReIrradiation With FDG-PET Guided Dose Painting for Recurrent and Second Primary Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
FDG-PET guided dose painting
Primary Outcome Measure Information:
Title
Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST).
Time Frame
6 months
Title
Number of participants with adverse events.
Description
Number of participants with toxicity using CTCAE v3.0.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einar Dale, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://helseforskning.etikkom.no/?_ikbLanguageCode=us
Description
Regional ethics committee

Learn more about this trial

ReIrradiation With FDG-PET Guided Dose Painting

We'll reach out to this number within 24 hrs