Trial record 1 of 1 for:    NCT00593840
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Phase II Trial Evaluating Elimination of Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593840
First received: January 2, 2008
Last updated: March 14, 2014
Last verified: March 2014
  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 the side effects of radiation treatment for head and neck cancer. In this study, we plan to reduce the amount of radiation treatment received 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:


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

Primary Outcome Measures:
  • Eliminate radiation of PN0 neck(s) and demonstrate >90% control in the unirradiated neck(s) [ Time Frame: 12 months of follow-up ] [ Designated as safety issue: No ]
    Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.


Secondary Outcome Measures:
  • Evaluate the rates of locoregional control, disease specific survival, overall survival, and patterns of failure [ Time Frame: 5 years from completion of treatment ] [ Designated as safety issue: No ]
  • Evaluate impact of treatment volume on toxicity and quality of life through the use of validated PRO QOL instruments with PTV as a continuous variable. [ Time Frame: Acute toxicity = through 90 days after completion of treatment, Late = from 90 days through patient's death ] [ Designated as safety issue: Yes ]
  • Compare standard treatment volume (CTV and PTV) with protocol defined treatment volume in terms of organ specific dose volume histograms [ Time Frame: Completion of treatment ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: April 2007
Estimated Study Completion Date: February 2019
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IMRT

CTV1 = 66 Gy in 33 fractions

CTV2 = 60 Gy in 33 fractions

CTV3 = 56 Gy in 33 fractions

CTV3 Proto = 56 Gy in 33 fractions

Radiation: IMRT

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593840

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Wade Thorstad, MD Washington University School of Medicine
  More Information

Additional Information:
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 14, 2014
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 August 19, 2014