Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer

• Status: Completed
• Trial end date: 2021-03-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Cisplatin; Paclitaxel

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