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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01427010
First received: August 29, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
Recurrent and Second Primary Squamous Cell Carcinoma of the Oropharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
Recurrent and Second Primary Squamous Cell Carcinoma of the Hypopharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
Recurrent and Second Primary Squamous Cell Carcinoma of the Larynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.
 Radiation: [18F]FDG-PET-voxel intensity-based IMRT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Estimation time to progression. [ Time Frame: At 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Evaluation tumor response. [ Time Frame: After 3 months. ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events. [ Time Frame: Up to 3 months. ] [ Designated as safety issue: No ]
    Evaluation acute toxicity.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reirradiation of recurrent and 2nd primary head/neck cancer. Radiation: [18F]FDG-PET-voxel intensity-based IMRT
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427010

Contacts
Contact: Wilfried De Neve, MD, PhD wilfried.deneve@uzgent.be

Locations
Belgium
Antwerp University Hospital Recruiting
Antwerp, Belgium
Principal Investigator: D. Van Gestel, MD            
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Wilfried De Neve, MD, PhD            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Wilfried De Neve, Ph.D., M.D. Ghent University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01427010     History of Changes
Other Study ID Numbers: 2011/536
Study First Received: August 29, 2011
Last Updated: January 29, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013