Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

All Conditions

Neoplasms

Rare Diseases

Laryngeal Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Laryngeal Cancer

-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.

Intensity modulated radiation therapy

Wade Thorstad, MD

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

Phase II Trial Evaluating Elimination of Radiation Therapy

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

* 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.

* 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

-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.

-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.

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.

Washington University School of Medicine

Arm 1: Intensity Modulated Radiation Therapy (IMRT)

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Oropharynx

Larynx

Oral cavity

Hypopharynx

Unknown

Primary tumor type

Tobacco abuse

Wade Thorstad, M.D.

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

Arm 1: IMRT

Number of Participants With a Recurrence in the Unirradiated Neck(s)

Kaplan Meier Estimate of Locoregional Recurrence Free Survival

65 out of 73 patients had evaluable QOL data in Arm 1.

Quality of Life (QOL) as Measured by Overall Global QOL Scores

Quality of Life (QOL) as Measured by Xerostomia QOL Data

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

Disease Specific Survival Rate

Kaplan Meier Estimate of Overall Survival

Patterns of Failure Associated With Implementation of Primary Objective

-Recurrence is defined as the return of cancer after treatment

Kaplan Meier Estimate of Regional Recurrence Free Survival

-Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Spots Global Cancer Trial Database for Phase II Trial Evaluating Elimination of Radiation Therapy

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