NCT02921581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4.9 years

First QC Date

September 27, 2016

Last Update Submit

December 12, 2024

Conditions

Head and Neck Cancer

Keywords

Dose painting18F-FDGPositron emission tomographyRadiotherapy

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (2)

  • Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST).

    6 months

  • Number of participants with adverse events.

    3 years

Interventions

FDG-PET guided dose paintingRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, N-0424, Norway

Location

Related Publications (1)

  • Skjotskift T, Evensen ME, Furre T, Moan JM, Amdal CD, Bogsrud TV, Malinen E, Dale E. Dose painting for re-irradiation of head and neck cancer. Acta Oncol. 2018 Dec;57(12):1693-1699. doi: 10.1080/0284186X.2018.1512753. Epub 2018 Oct 3.

    PMID: 30280623BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Einar Dale, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 3, 2016

Study Start

June 1, 2015

Primary Completion

May 1, 2020

Study Completion

August 1, 2023

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations

NO(1)