Adult Clinical Trials: HEAD AND NECK
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
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 and or Lymphovascular invasion;
◦ Single lymph node > 3cm or > 2 lymph nodes (all < 6cm) (no extracapsular extension);
◦ Close margin (s) of resection, defined as cancer extending to within 5mm of a surgical margin;
◦ T3 or microscopic T4a primary tumor (Note: Gross T4a or T4b is ineligible);
◦ T2 oral cavity cancer with > 5mm depth of invasion.
• Adequate bone marrow, hepatic, and renal function as specified in the protocol;
• 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.
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.
A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
- Pathologically proven diagnosis of a malignant major salivary gland tumor of the following histologic subtypes: high grade mucoepidermoid carcinoma, salivary duct carcinoma or high grade adenocarcinoma
- Surgical resection with curative intent within 8 weeks prior to registration; Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (<1mm) or microscopically positive surgical margin
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
- Patients must be deemed able to comply with the treatment plan and follow-up schedule.
Arm 1: Radiation: 60-66 Gy in 2 Gy daily fractions and Cisplatin: 40 mg/m2 weekly during radiation
for 7 doses
Arm 2: Radiation: 60-66 Gy in 2 Gy daily fractions
Phase III Trial of Radiotherapy plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Pathologic staging of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal).
Clinical stage of T1-2, N2a-N3, or T3-4, any N including no distant metastasis
No oral tongue, floor of mouth, alveolar ridge, buccal or lip cancer for this study ), nasopharynx, hypopharynx, or larynx. Cancer of the neck of unknown primary origin does not qualify for this study. Stage T1-2, N0-1 can not participate in this study.
Must be HPV positive to participate in this study. Tissue must be sent off for analysis to RTOG lab for confirmation of diagnosis.
Arm I: Accelerated IMRT, 70 Gy for 6 weeks + high dose Cisplatin (100mg/m) Days 1 and 22
Arm II: Accelerated IMRT, 70 Gy for 6 weeks + 8 doses of cetuximab (400mg/m) loading dose pre-IMRT, 250mg/m weekly during IMRT and for 1 week after IMRT.