Head and Neck Cancer
Conditions
Brief summary
To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)
Detailed description
Patients are assigned to either elective nodal irradiation (ENI), the current treatment paradigm, or involved nodal radiotherapy (INRT), the experimental treatment. INRT is more specifically targeting potentially cancerous nodes, identified using an AI program developed in-house. The hope is that this more specific targeting will decrease healthy tissue being irradiated, therefore decreasing potential side effects of the radiation treatment. Patients are blinded during study participation.
Interventions
DRUGENI using IMRT with or without chemotherapy
This study is a phase II single-blinded randomized trial comparing standard ENI with involved nodal radiotherapy. INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)
RADIATIONINRT
INRT using intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin- paclitaxel)
RADIATIONENI
ENI using IMRT with or without chemotherapy
Sponsors
University of Texas Southwestern Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients are blinded to their treatment.
Intervention model description
radiation ENI versus INRT
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed. * Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (≤ 2 nodes) is also allowable. * Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer. * Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded * Age ≥ 18 years. * ECOG Performance Status 0-2 * All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Neck CT and/or neck MRI, and PET-CT * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Distant metastasis. * Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast. * Inability to undergo PET-CT. * Stage I and II glottic carcinoma. * Gross total excision of both the primary and nodal disease. * Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met. * Prior invasive malignancy with an expected disease-free interval of less than 3 years. * Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. * Subjects may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. * History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The probability at two years: SEVR in INRT versus ENI patients | 2 years | The probability at two years will be compared between the arms using a one- sided Fisher's exact test (probability of SEVR between the arms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Grade 2+ Dermatitis between ENI vs INRT arms | Start of RT through 90 days post RT | Comparison of instances of grade 2+ acute dermatitis between patients treated with INRT (involved nodal radiotherapy, study treatment) vs ENI (elective nodal irradiation, standard of care). This will be compared between the arms using a Fisher exact test (2-sided). |
| Incidence of Grade 3+ Dysphagia between ENI vs INRT arms | 2 years post RT | Comparison of instances of grade 3+ dysphagia between patients treated with INRT (involved nodal radiotherapy, study treatment) vs ENI (elective nodal irradiation, standard of care). This will be compared between the arms using a Fisher exact test (2-sided). |
| MDADI Quality of Life composite score | 2 years post RT | Comparison of MDADI composite scores at 2 years post RT between patients treated with INRT (involved nodal radiotherapy, study treatment) vs ENI (elective nodal irradiation, standard of care). Patients with disease recurrence will be excluded from analysis. At two years, both scores will be compared between the arms using a two-sided T test. |
Countries
United States
Contacts
CONTACTSarah Neufeld
CONTACTLiliana Robles
PRINCIPAL_INVESTIGATORDavid Sher, MD
University of Texas Southwestern Medical Center
Outcome results
None listed