Clinical trial NCT00720070: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-07-22
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Overall survival at 2 years
measure: Health economics using quality adjusted life years
Secondary outcomes:
measure: Disease-specific survival
measure: Recurrence and local control in neck
measure: Utility cost
measure: Quality of life
measure: Complication rates
measure: Accuracy of PET-CT scanning for assessing primary tumor
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Warwick Medical School Clinical Trials Unit
state: England
Study officials:
affiliation: Warwick Medical School
name: Hisham Mehanna, MD
role: PRINCIPAL_INVESTIGATOR
References: