Skip to main content
OpenTrials
Completed

NCT Number: NCT01427010

A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

Adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also be of importance in IMRT for recurrent and second primary head and neck cancers in previously irradiated territory.

This trial investigates the feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography-voxel ([18F]FDG-PET-voxel) intensity-based IMRT in reirradiation of patients with recurrent and second primary head and neck cancer.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory.
  • Primary unresectable tumor and/or patients refused surgery.
  • No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer.
  • Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer.
  • Decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab)
  • Karnofsky performance status ≥70%.
  • Age ≥ 18 years old.
  • Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion criteria

  • Previous radiotherapy for cT1-2 cN0 M0 glottic cancer.
  • Brachytherapy as treatment for second primary / recurrence.
  • Distant metastases.
  • Other second primary tumors that are not under control.
  • Pregnant or lactating women.
  • Elevated blood creatinine level.
  • Allergy to the CT-contrast agents.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Treatment and study plan

[18F]FDG-PET-voxel intensity-based IMRT

Radiation

Non-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment.

Primary outcomes

  1. To test success rate of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy).

    Time frame: 2 year

    To test feasibility of continuous adaptive 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-guided radiotherapy (intensity-modulated radiotherapy (IMRT) and/or helical tomotherapy) in treatment of recurrent and second primary head and neck cancer in the previously irradiated territory.

Secondary outcomes

  1. Estimation time to progression.

    Time frame: At 6, 9 and 12 months

  2. Evaluation tumor response.

    Time frame: After 3 months.

  3. Number of Participants with Adverse Events.

    Time frame: Up to 3 months.

    Evaluation acute toxicity.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 1, 2011
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.