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 - Full Text View

Sponsored by:	Warwick Medical School Clinical Trials Unit
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00720070

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Procedure: computed tomography Procedure: positron emission tomography Procedure: therapeutic conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Head and Neck Cancer Nuclear Scans Radiation Therapy Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival at 2 years [ Designated as safety issue: No ]
Health economics using quality adjusted life years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-specific survival [ Designated as safety issue: No ]
Recurrence and local control in neck [ Designated as safety issue: No ]
Utility cost [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Complication rates [ Designated as safety issue: Yes ]
Accuracy of PET-CT scanning for assessing primary tumor [ Designated as safety issue: No ]

Estimated Enrollment:	560
Study Start Date:	September 2007
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720070

Locations

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

Sponsors and Collaborators

Warwick Medical School Clinical Trials Unit

Investigators

Principal Investigator:

Hisham Mehanna, MD

Warwick Medical School Clinical Trials Unit

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000597895, WMS-PET-NECK, ISRCTN13735240, EU-20856, MREC-07/Q1604/35, UKCRN ID: 3799
Study First Received:	July 19, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00720070 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Laryngeal Carcinoma
Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasm Metastasis

Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Hypopharyngeal Cancer
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 09, 2009