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
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Diagnostic
Outcome Measure:
Overall survival at 2 years
Safety Issue:
No
Principal Investigator
Hisham Mehanna, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Warwick Medical School
Authority:
Unspecified
Study ID:
CDR0000597895
NCT ID:
NCT00720070
Start Date:
September 2007
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage I squamous cell carcinoma of the larynx
- stage I verrucous carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
- 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 I verrucous carcinoma of the oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage I squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- tongue cancer
- Head and Neck Neoplasms
- Neoplasm Metastasis
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