Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
Condition: Head and Neck Cancer; Carcinoma, Squamous Cell; Neoplasms, Oral; Neoplasms, Pharyngeal
MeSH terms: Carcinoma; Neoplasms; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Mouth Neoplasms; Pharyngeal Neoplasms
Intervention: Intensity Modulated Radiation Therapy; chemotherapy
Intervention description: 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
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: radiation therapy
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

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

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