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NCT Number: NCT00593840

Phase II Trial Evaluating Elimination of Radiation Therapy

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer of the Larynx Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensity modulated radiation therapy

Radiation

Other names: IMRT

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

  4. Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms

    Time frame: Completion of follow-up (minimum of 5 years from completion of treatment)

  5. Disease Specific Survival Rate

    Time frame: Completion of follow-up (minimum of 5 years from completion of treatment)

  6. Kaplan Meier Estimate of Overall Survival

    Time frame: 3 years

  7. Patterns of Failure Associated With Implementation of Primary Objective

    Time frame: Completion of follow-up (minimum of 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy

Important dates

Study start
2007
Primary completion
2014
Study completion
2027
First posted
Jan 15, 2008
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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