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

A Multi-centre Randomised Phase III Trial Comparing PET-CT Guided Watch and Wait Policy Versus Planned Neck Dissection for the Management of Locally Advanced (N2/N3) Nodal Metastases in Patients With Head and Neck Squamous 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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Procedure: positron emission tomography/computed tomography; Procedure: therapeutic conventional surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Coventry, England, United Kingdom, CV4 7AL
      • Recruiting
      • Warwick Medical School Clinical Trials Unit
      • Contact: Hisham Mehanna, MD; Phone Number: 44-247-696-5606

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: positron emission tomography/computed tomography; Patients undergo PET/CT scan; Procedure: therapeutic conventional surgery; Patients undergo neck dissection
Active Comparator: Arm II; Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.	Procedure: positron emission tomography/computed tomography; Patients undergo PET/CT scan; Procedure: therapeutic conventional surgery; Patients undergo neck dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival at 2 years
Health economics using quality adjusted life years

Secondary Outcome Measures

Outcome Measure
Quality of life
Complication rates
Disease-specific survival
Recurrence and local control in neck
Utility cost
Accuracy of PET-CT scanning for assessing primary tumor

Collaborators and Investigators

• Sponsor: Warwick Medical School
• Investigators: Principal Investigator: Hisham Mehanna, MD, Warwick Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: July 19, 2008
• First Submitted That Met QC Criteria: July 19, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: stage III squamous cell carcinoma of the lip and oral cavity; stage III verrucous carcinoma of the oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the oropharynx; tongue cancer; stage I verrucous carcinoma of the oral cavity; stage II verrucous carcinoma of the oral cavity; stage I verrucous carcinoma of the larynx; stage II verrucous carcinoma of the larynx
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CDR0000597895; WMS-PET-NECK; ISRCTN13735240; EU-20856; MREC-07/Q1604/35; UKCRN ID: 3799