A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer

NCT01208883 | Completed Phase 1

• 1 other identifier: 2010/510
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment \[18F\]FDG-PET acquired during treatment in adaptive \[18F\]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.

Conditions

Squamous Cell Carcinoma

Keywords

Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.

Outcome Measures

Primary Outcomes (1)

• To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.

  at time of per-treatment [18F]FDG-PET/CT

Study Arms (1)

repetitive per-treatment [18F]FDG-PET for treatment adaptation

EXPERIMENTAL

Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation

Interventions

repetitive per-treatment [18F]FDG-PET for treatment adaptation OTHER

repetitive per-treatment \[18F\]FDG-PET for treatment adaptation

repetitive per-treatment [18F]FDG-PET for treatment adaptation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
• Primary unresectable tumor and/or patients refused surgery.
• Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
• Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
• Karnofsky performance status ≥70%.
• Age ≥ 18 years old.
• Informed consent obtained, signed and dated before specific protocol procedures.

You may not qualify if:

• Treatment combined with brachytherapy.
• Prior irradiation to the head and neck region.
• Distant metastases.
• Second primary tumors that are not under control
• Pregnant or lactating women.
• Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent, Belgium

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Wilfried De Neve, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

BE (1)