Cancer of the Larynx
Conditions
Brief summary
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
Interventions
RADIATIONIntensity modulated radiation therapy
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Recurrence in the Unirradiated Neck(s) | 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
| Measure | Time frame | Description |
|---|---|---|
| Kaplan Meier Estimate of Locoregional Recurrence Free Survival | 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 | 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 | 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 | Completion of follow-up (minimum of 5 years from completion of treatment) | — |
| Disease Specific Survival Rate | Completion of follow-up (minimum of 5 years from completion of treatment) | — |
| Kaplan Meier Estimate of Overall Survival | 3 years | — |
| Patterns of Failure Associated With Implementation of Primary Objective | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWade Thorstad, MD
Washington University School of Medicine
Participant flow
Recruitment details
The study opened to accrual on 04/11/2007 and closed to accrual 04/07/2014.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: 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. | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | Arm 1: Intensity Modulated Radiation Therapy (IMRT) |
|---|---|
| Age, Continuous | 56 years |
| Primary tumor type Hypopharynx | 4 participants |
| Primary tumor type Larynx | 17 participants |
| Primary tumor type Oral cavity | 14 participants |
| Primary tumor type Oropharynx | 37 participants |
| Primary tumor type Unknown | 1 participants |
| Region of Enrollment United States | 73 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 59 Participants |
| Tobacco abuse No | 26 participants |
| Tobacco abuse Yes | 47 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 72 / 72 |
| serious Total, serious adverse events | 7 / 72 |
Outcome results
Primary
Number of Participants With a Recurrence in the Unirradiated Neck(s)
* 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.
Time frame: 12 months of follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: IMRT | Number of Participants With a Recurrence in the Unirradiated Neck(s) | 0 participants |
Secondary
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)
Secondary
Disease Specific Survival Rate
Time frame: Completion of follow-up (minimum of 5 years from completion of treatment)
Secondary
Kaplan Meier Estimate of Locoregional Recurrence Free Survival
* 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
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: IMRT | Kaplan Meier Estimate of Locoregional Recurrence Free Survival | 88.6 percentage of participants-Kaplan Meier |
Secondary
Kaplan Meier Estimate of Overall Survival
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: IMRT | Kaplan Meier Estimate of Overall Survival | 75.8 percentage of participants-Kaplan Meier |
Secondary
Patterns of Failure Associated With Implementation of Primary Objective
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.
Time frame: Completion of follow-up (minimum of 5 years from completion of treatment)
Secondary
Quality of Life (QOL) as Measured by Overall Global QOL Scores
-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.
Time frame: Median follow-up was 22 months
Population: 65 out of 73 patients had evaluable QOL data in Arm 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IMRT | Quality of Life (QOL) as Measured by Overall Global QOL Scores | 59.1410 units on a scale | Standard Deviation 34.8294 |
Secondary
Quality of Life (QOL) as Measured by Xerostomia QOL Data
-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.
Time frame: Median follow-up was 22 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IMRT | Quality of Life (QOL) as Measured by Xerostomia QOL Data | 39.5584 units on a scale | Standard Deviation 26.0941 |
Post Hoc
Kaplan Meier Estimate of Progression-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.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: IMRT | Kaplan Meier Estimate of Progression-free Survival | 68.9 percentage of participants-Kaplan Meier |
Post Hoc
Kaplan Meier Estimate of Regional Recurrence Free Survival
-Recurrence is defined as the return of cancer after treatment
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: IMRT | Kaplan Meier Estimate of Regional Recurrence Free Survival | 94.8 percentage of participants-Kaplan Meier |