Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
This study aims to significantly improve the acute and late morbidity of patients with oropharyngeal and laryngeal squamous cell carcinoma both by tailoring the elective irradiation only to regions with a legitimate risk of recurrence (\> 5%) and by lowering the elective dose to 40 Gy. Level IB will not be electively treated unless it is involved with pathologic or suspicious lymphadenopathy. Level V will not be treated unless two or more ipsilateral nodal levels are involved (or level V itself has pathologic or suspicious adenopathy). Levels III and IV will only be irradiated if the immediately proximal level contains pathologic lymphadenopathy (i.e. level III irradiated if level II is positive; level IV irradiated if level III is positive). We anticipate that this approach should dramatically improve the acute and late complication profile.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
Rush University Medical Center
Chicago, Illinois, United States
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Number of Patients With Solitary Elective Volume Recurrence
The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator.
Time frame: 2 years
Quality of Life (QOL) Patient Reported Outcomes (PRO)
Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
Time frame: 12 months
Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria.
Time frame: 2 years
Total Number of Participants With Gastrostomy Dependence
The prevalence of gastrostomy use up to 2 years will be described.
Time frame: 2 years
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Patient Utilities
The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE).
Time frame: 2 years
Overall Survival
Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method.
Time frame: 2 years
Progression-free Survival
Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression.
Time frame: 2 year
Probability of Locoregional or Distant Tumor Failure
The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death.
Time frame: 2 years