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 : March 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Radiation: FDG-PET guided dose painting | Not Applicable |
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 : | 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 |

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

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

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
Contact: Einar Dale, MD PhD | eindal@ous-hf.no |
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 |
Principal Investigator: | Einar Dale, MD PhD | Oslo University Hospital |
Responsible Party: | Einar Dale, Senior Consultant, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT02921581 |
Other Study ID Numbers: |
2015/118 |
First Posted: | October 3, 2016 Key Record Dates |
Last Update Posted: | March 11, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Dose painting 18F-FDG Positron emission tomography Radiotherapy |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |