PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer
PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body
 and may help doctors detect residual disease and plan the best treatment. Neck dissection is
 surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a
 neck dissection should always be performed in treating patients with head and neck cancer.

 PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting
 compared with neck dissection of locally advanced lymph node metastases in treating patients
 who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.
OBJECTIVES:

 -  To compare the efficacy, in terms of overall survival, disease-specific survival,
 recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and
 wait policy with the current practice of planned neck dissection in the management of
 advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous
 cell carcinoma undergoing chemoradiotherapy.

 -  To assess the predictive value of PET/CT scanning in detecting persistent or residual
 disease in the primary site.

 OUTLINE: This is a multicenter study. Patients are stratified according to center,
 chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and
 concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent
 platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are randomized
 to 1 of 2 treatment arms.

 -  Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo
 PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of
 primary site undergo neck dissection within 4 weeks.

 -  Arm II: Patients undergo neck dissection and then receive standard CRT. Patients undergo
 PET/CT scan at 9-13 weeks after completion of CRT.

 Patients are assessed periodically for quality-of-life. Tissue and blood samples collected
 periodically are stored for future research.

 After completion of study treatment, patients are followed monthly for 1 year and then
 bimonthly for 1 year.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed head and neck squamous cell carcinoma (HNSCC), including any
 of the following subtypes:

 -  Oropharyngeal

 -  Laryngeal

 -  Oral

 -  Hypopharyngeal

 -  No primary nasopharyngeal carcinoma

 -  Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or
 N3

 -  No occult nodal metastasis (i.e., large nodal metastasis but no proven primary
 site on clinical assessment)

 -  No N1 nodal metastasis

 -  Planning to receive curative radical concurrent chemoradiotherapy (approved by study)
 for primary disease

 -  Patients undergoing neoadjuvant chemotherapy followed by concurrent
 chemoradiotherapy are eligible

 -  Able to undergo neck dissection surgery

 -  No current resection for primary tumor planned (e.g., resection of tonsil or base of
 tongue with flap reconstruction [diagnostic tonsillectomy allowed])

 -  No distant metastases to chest, liver, bones, or other sites

 PATIENT CHARACTERISTICS:

 -  Not pregnant

 -  No other cancer diagnosis within the past 5 years except basal cell carcinoma or
 cervical carcinoma in situ

 PRIOR CONCURRENT THERAPY:

 -  See Disease Characteristics

 -  No prior treatment for HNSCC

 -  No concurrent neoadjuvant chemoradiotherapy without concurrent chemotherapy

 -  No concurrent adjuvant chemotherapy

 -  No concurrent chemoradiotherapy for palliative purposes

 -  No concurrent radiotherapy alone