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

Warwick Medical School

Status and phase: Unknown; Phase 3

Conditions: Head and Neck Cancer

Treatments: Procedure: therapeutic conventional surgery; Procedure: positron emission tomography/computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT00720070

ISRCTN13735240

CDR0000597895

EU-20856

WMS-PET-NECK

UKCRN ID: 3799

MREC-07/Q1604/35

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

560 participants in 2 patient groups

Arm I

Experimental group

Description:

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.

Treatment:

Procedure: therapeutic conventional surgery

Procedure: positron emission tomography/computed tomography

Arm II

Active Comparator group

Description:

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

Treatment:

Procedure: therapeutic conventional surgery

Procedure: positron emission tomography/computed tomography