Clinical trial NCT03067610: Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
Official title: A Prospective Phase II Study of Involved Field Elective Volume De-Intensification for Oropharyngeal and Laryngeal Squamous Cell Carcinoma Treated With Intensity Modulated Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Carcinoma, Squamous Cell
Neoplasms, Oral
Neoplasms, Pharyngeal
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: radiation therapy
Primary purpose: TREATMENT

Brief summary: Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx or larynx. 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. Patients may undergo a diagnostic tonsillectomy, and diagnostic lymph node excision (\< 2 nodes) is also allowable.
* Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
* Age ≥ 18 years.
* ECOG Performance Status 0-2
* Adequate organ and marrow function as defined below:
* leukocytes ≥ 3,000/mcL
* absolute neutrophil count ≥ 1,500/mcL
* platelets ≥ 100,000/mcl
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, 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).
* Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
* Neck CT and/or neck MRI, and whole body PET-CT.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Distant metastasis or adenopathy below the clavicles.
* Inability to undergo PET-CT.
* Stage I and II glottic carcinoma.
* Gross total excision of both the primary and nodal disease.
* Synchronous primaries outside of the oropharynx and larynx.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 1 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 would limit compliance with study requirements.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
* History of immunosuppression or autoimmunity, including HIV, and organ or stem cell transplant, or an autoimmune condition previously treated with immunosuppressive therapy

Primary outcomes:
measure: Number of Patients With Solitary Elective Volume Recurrence
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life (QOL) Patient Reported Outcomes (PRO)
timeFrame: 12 months
measure: Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5)
timeFrame: 2 years
measure: Total Number of Participants With Gastrostomy Dependence
timeFrame: 2 years
measure: Patient Utilities
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Progression-free Survival
timeFrame: 2 year
measure: Probability of Locoregional or Distant Tumor Failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: U Texas Southwestern Medical Center
name: David Sher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: