Summaries - Head and Neck Head & Neck Cancer Protocols 0920 Number: RTOG 0920 Title: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer Eligibility: Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases; Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration with surgical pathology demonstrating one or more of the following "intermediate" risk factors: Perineural invasion; Lymphovascular invasion; Single lymph node > 3 cm or > 2 lymph nodes (all < 6 cm) [no extracapsular extension]; Close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin; T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is ineligible); T2 oral cavity cancer with > 5 mm depth of invasion. Zubrod Performance Status of 0-1 within 2 weeks prior to registration; Age > 18; adequate bone marrow, hepatic, and renal function as specified in the protocol; Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control; Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for EGFR and for oropharyngeal patients, HPV analyses. RT Alone versus RT + Cetuximab Arm 1: Radiation Therapy Alone, 2 Gy/day, in 30 fractions for a total of 60 Gy*Arm 2: Radiation Therapy + Cetuximab At least 5 days prior to RT: Cetuximab: Initial dose, 400 mg/m2 RT: 2 Gy/day in 30 fractions for a total of 60 Gy* plus cetuximab, 250 mg/m2/week x 6 weeks plus cetuximab: 250 mg/m2/week x 4 weeks post-RT *IMRT is mandatory. Dose is 60 Gy prescribed to at least 95% of the PTV. If IGRT is used, it should be daily to assure that error/variance is < 3.5 mm. Note: 66 Gy is permitted and optional. Note: Prior to stratification and randomization, all patients must consent to submission of tissue for required EGFR analysis; analysis results are expected in approximately 7-8 business days. At that time, patients with non-oropharyngeal carcinoma can be randomized. In addition, patients with oropharyngeal carcinoma must consent to use of the submitted tissue for required HPV analysis; analysis results are expected in approximately 7-10 business days. At that time, patients with oropharyngeal carcinoma can be randomized. All institutions will receive a 0.5 case credit for submission of tissue for analysis. See Section 5.5 for details of registration/randomization. Study size: 700 0619 Number: RTOG 0619 Title: A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head And Neck Eligibility: Pathologically (histologically or cytologically) proven AJCC pathological stage III or IV (note that the preoperative clinical stage may be I-IV) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses); Gross total resection (with curative intent) must be completed within 3 to 6 weeks of registration, with pathology demonstrating one or more of the following risk factors: Histologic extracapsular nodal extension; Invasive cancer seen on microscopic evaluation of the resection margin, when all visible tumor has been removed. Surgical resection of the microscopic involved margin is NOT permitted. Note: Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible if the patient has formal neck dissection confirming histologic extracapsular nodal extension. Appropriate stage for protocol entry, including no distant metastases; Zubrod Performance Status 0-1; Age > 18; Adequate bone marrow, renal, and hepatic function as specified in the protocol; Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study. Patient must sign a study-specific informed consent prior to study entry, which includes mandatory submission of tissue for pathology central review and for patients with oropharyngeal carcinoma, mandatory submission of tissue for HPV analysis. Chemoradiotherapy +/- Vandetanib Arm 1: Chemoradiotherapy Cisplatin, 100 mg/m2, beginning on day 1 of RT, every 3 weeks for 3 cycles Radiation: 5.5-6.5 weeks; total dose of 58-66 Gy Arm 2: Chemoradiotherapy + Vandetanib Vandetanib, 100 mg, daily Note: Vandetanib will begin 14 days prior to start of RT and no earlier than 3 weeks after surgery. Vandetanib continues for 6 weeks or until radiation is completed Cisplatin, 30 mg/m2, on day 1 of RT, weekly for 6 weeks Radiation: 5.5-6.5 weeks; total dose of 58-66 Gy Study size: 170 RTOG 0537 Number: RTOG 0537 Title: A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia Eligibility: Complete history and physical examination to demonstrate no clinical evidence of disease recurrence, including an ENT exam with a nasopharyngeal scope, if indicated, 8 weeks prior to registration; CT or MRI scan within 8 weeks prior to registration; Patients who have completed RT (standard or IMRT) +/- chemotherapy for head and neck cancers at least 3 months prior to study entry and who have grade 1-2 xerostomia according to the CTCAE v.3.0 salivary gland changes/saliva xerostomia scale and the dry mouth/salivary gland xerostomia scale; Must have evidence of residual salivary function with unstimulated WSP of at least 0.25 ml/min (having refrained from eating or drinking oral fluid for 2 hours prior); Patients who have received pilocarpine previously are eligible; patients must discontinue prior pilocarpine within 2 weeks prior to randomization; Zubrod performance status of 0-2;Age > 18 years; Serum pregnancy test for women of childbearing potential; women of childbearing potential and male participants must practice adequate contraception;Patient must be able to provide study-specific informed consent prior to study entry. No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); No patients with normal saliva production (no salivary gland changes; no xerostomia); No patients who have previously received and discontinued pilocarpine due to serious adverse events; No patients with current contraindications to pilocarpine (e.g., uncontrolled asthma, miosis, hypersensitivity); No patients who are on pilocarpine for ophthalmic or non-ophthalmic indications; Nopatients who are on medications which will induce xerostomia (e.g., tricyclic antidepressants, antihistamines with anticholinergic effects or narcotics); No severe, active co-morbidity as defined in the protocol; No pregnant females, as ALTENS stimulates acupuncture points that may be related to the Conception Meridian and, in theory, may affect uterine function. Treatment Phase II Component ALTENS (given with Codetron®) 2x weekly for 12 weeks Phase III Component Stratify: Prior use of pilocarpine Time from cancer treatment Randomize: Arm 1: Pilocarpine, t.i.d., for 12 weeks Arm 2: ALTENS (given with Codetron®) 2x weekly for 12 weeks Study size: Phase II component, 45 patients Phase III component, 144 patients 0514 Number: RTOG 0514 Title: Establishment Of A Head And Neck Cancer Tissue/Specimen Bank Eligibility: Patients must have a suspected or confirmed diagnosis of head and neck cancer and must be potentially eligible for an active RTOG treatment study. Patients with biopsy proven recurrent cancer at the primary site also are eligible if they are potentially eligible for an RTOG treatment study for patients with recurrent disease or if they fail on an RTOG treatment study which collects specimens at the time of recurrence. Zubrod Performance Status 0-1; Age > 18; Patient must sign a study specific informed consent for RTOG 0514 prior to submission of specimens. Study size: N/A, Ongoing Prospective Tissue/Specimen Bank Research Study