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Phase II Trial Evaluating Elimination of Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593840
First Posted: January 15, 2008
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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, the investigators plan to reduce the amount of radiation treatment received to healthy tissue

Condition Intervention Phase
Cancer of the Larynx Radiation: Intensity modulated radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Number of Participants With a Recurrence in the Unirradiated Neck(s) [ Time Frame: 12 months of follow-up ]
    • Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.
    • Recurrence is defined as the return of cancer after treatment
    • Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.


Secondary Outcome Measures:
  • Kaplan Meier Estimate of Locoregional Recurrence Free Survival [ Time Frame: 3 years ]
    • Recurrence is defined as the return of cancer after treatment
    • Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame

  • Quality of Life (QOL) as Measured by Overall Global QOL Scores [ Time Frame: Median follow-up was 22 months ]
    -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.

  • Quality of Life (QOL) as Measured by Xerostomia QOL Data [ Time Frame: Median follow-up was 22 months ]
    -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.

  • Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms [ Time Frame: 5 years from completion of treatment ]
  • Disease Specific Survival Rate [ Time Frame: 5 years from completion of treatment ]
  • Kaplan Meier Estimate of Overall Survival [ Time Frame: 3 years ]
  • Patterns of Failure Associated With Implementation of Primary Objective [ Time Frame: 5 years from completion of treatment ]
    For patients who demonstrate a local failure during follow-up, a computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imagine (MRI) scan is fused with the original treatment planning CT scan using the computational environment for radiation research (CERR) developed at Washington University Medical Center. The methodology to transfer the digital imaging study via network to the radiation therapy research servers is mature. The original dose distribution and contours are correlated with the recurrent disease noted on the follow up imaging study. The recurrence is then classified as infield, marginal to the treatment field, or out of the treatment field depending on the dose received by the recurrent disease. Failures that occur in the treatment field are due to aspects of tumor biology rather than errors in the volume irradiated. As has been the case in our historical controls, the investigators expect most failures to be in the treatment field.


Enrollment: 73
Study Start Date: April 2007
Estimated Study Completion Date: April 2019
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensity modulated radiation therapy (IMRT)
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
Radiation: Intensity modulated radiation therapy
Other Name: IMRT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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, Institutional Review Board (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593840


Locations
United States, Missouri
Washington University School of Medicine
Saint 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:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593840     History of Changes
Other Study ID Numbers: 07-0142 / 201106342
First Submitted: January 2, 2008
First Posted: January 15, 2008
Results First Submitted: June 9, 2016
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: April 2017

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