Adult Clinical Trials:HEAD AND NECK

RTOG  0514:  HEAD AND NECK

Establishment of a Head and Neck Cancer/Tissue Specimen Bank

• Patients must have a suspected diagnosis of untreated head and neck cancer and must be eligible for an active RTOG study.

RTOG 0522: HEAD AND NECK

A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas

• Histologically proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; Selected stage III or IV disease (T2N2-3M0, T3-4 any N M0); no distant metastases
• No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• No prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; No primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands.
• No initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
• No severe, active co-morbidity.

Treatment

Arm 1: Accelerated Fractionation by Concomitant Boost (AFX-CB) or IMRT plus cisplatin

Arm 2: Accelerated Fractionation by Concomitant Boost(AFX-CB) or IMRT plus cisplatin; plus cetuximab

8-9 Weeks Post-Treatment Reassessment

Selected Patients: Required Neck Dissection

RTOG 0615: HEAD AND NECK

A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) [NSC 708865; IND 7921] for Locally or Regionally Advanced Nasopharyngeal Cancer

• Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of Stage IIB-IVB (AJCC, 6th ed.) non-metastatic cancer of the nasopharynx
•  Patients who present with T1-2N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes are not eligible.)
• Histologic types WHO I-IIb/III
•  Zubrod Performance Status 0-1 and Age > 18
•  Adequate bone marrow function, renal function, and hepatic function as defined in the protocol
•  The patient must have the nutritional and physical condition considered to be compatible with the proposed treatment regimen
• Negative serum pregnancy test 2 weeks prior to registration; Patients must sign study specific informed consent prior to registration.

Treatment

Concurrent phase: 3D-CRT or IMRT, Cisplatin, and Bevacizumab
Adjuvant phase: 5-Fluorouracil, Cisplatin, and Bevacizumab
Maintenance phase: Bevacizumab