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Phase II Trial Evaluating Elimination of Radiation Therapy

This study is currently recruiting participants.
Verified March 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593840
First received: January 2, 2008
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare you of the side effects of radiation treatment for head and neck cancer. In this study, we plan to reduce the amount of radiation treatment you receive to healthy tissue


Condition Intervention Phase
Cancer of the Larynx
 Radiation: IMRT
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. Other endpoints include locoregional control, overall survival, disease specific survival, patterns of failure, relationship between treatment volume and QOL measures [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 69
Study Start Date: February 2007
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Elimination of Neck Irradiation in the Pathological N0 Patient. The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the patient of side effects of radiation treatment for head and neck cancer. In this study, we plan to reduce the amount of radiation treatment the patient receives to healthy tissue to se if patients experience fewer side effects while still obtaining effective treatment for their cancer.
 Radiation: IMRT
Elimination of Neck Irradiation in the Pathological N0 Patient

Detailed Description:

The proposed study will prospectively test whether this method of volume reduction can be implemented without a change in the historical institutional locoregional control rate achieved with intensity modulated postoperative radiation therapy (IMPORT). Quality of life measurements via validated instruments will be incorporated to establish correlation of volume reduction with QOL.

  Eligibility

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

Inclusion Criteria:

  • Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx .
  • Treated with surgical resection with one (or both) side(s) of the neck pathologically N0.

  • Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics:

    • Close margin (< 0.5 cm)
    • Positive margin
    • Perineural invasion
    • Lymphovascular space invasion
    • Metastatic disease in more than one lymph node
    • Metastatic disease in more than one lymph node group
    • Extracapsular extension in any lymph node
    • Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion.
  • Age > 18.
  • Patients must sign study specific, IRB-approved consent form.

Exclusion Criteria:

  • Previous head and neck cancer other than non melanoma skin cancer.
  • Previous head and neck surgery.
  • Female patients who are pregnant or nursing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593840

Contacts
Contact: Wade Thorstad, MD (314) 362-8516 thorstad@radonc.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Wade Thorstad, M.D.     314-362-8516     thorstad@radonc.wustl.edu    
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Wade Thorstad, MD Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

Publications:
Chao, K.S., et al., Patterns of failure in patients receiving definitive and postoperative IMRT for head-and-neck cancer. Int J Radiat Oncol Biol Phys, 2003. 55(2): p. 312-21.
O'Sullivan, B., et al., The benefits and pitfalls of ipsilateral radiotherapy in carcinoma of the tonsillar region. Int J Radiat Oncol Biol Phys, 2001. 51(2): p. 332-43.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593840     History of Changes
Other Study ID Numbers: 07-0142 / 201106342
Study First Received: January 2, 2008
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
 Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013