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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00720070
• Other study ID #: CDR0000597895
• Secondary ID: WMS-PET-NECKISRC
• Status: Recruiting
• Phase: Phase 3
• First received: July 19, 2008
• Last updated: August 23, 2013
• Start date: September 2007

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• positron emission tomography/computed tomography
Patients undergo PET/CT scan
• therapeutic conventional surgery
Patients undergo neck dissection

Locations

Country	Name	City	State
United Kingdom	Warwick Medical School Clinical Trials Unit	Coventry	England

Sponsors (1)

Lead Sponsor	Collaborator
Warwick Medical School

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 2 years			No
Primary	Health economics using quality adjusted life years			No
Secondary	Disease-specific survival			No
Secondary	Recurrence and local control in neck			No
Secondary	Utility cost			No
Secondary	Quality of life			No
Secondary	Complication rates			Yes
Secondary	Accuracy of PET-CT scanning for assessing primary tumor			No