Neck Surgery in Treating Patients With Early-Stage Oral Cancer - Full Text View

Sponsored by:	The Facial Surgery Research Foundation
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00571883

Purpose

RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer.

PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer.

Condition	Intervention
Head and Neck Cancer	Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration Procedure: regional lymph node dissection Procedure: therapeutic conventional surgery

MedlinePlus related topics: Cancer Head and Neck Cancer Oral Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	SEND Trial The Role of Selective Neck Dissection Used Electively in Patients With Early Oral Squamous Cell Carcinoma (1-3cm Primary Size) and No Clinical Evidence of Lymph Node Metastases in the Neck

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

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]
Local and regional recurrence [ Designated as safety issue: No ]
Completeness of resection at the primary site [ Designated as safety issue: No ]
Quality-of-life as measured by the EORTC QLQ-30 & H&N module [ Designated as safety issue: No ]
Psychological well-being as measured by the Hospital Anxiety and Depression Scale (HADS) at 6, 12, and 24 months [ Designated as safety issue: No ]
Costs to NHS, patients, and carers/families [ Designated as safety issue: No ]
Incremental cost per life-year saved and/or per quality-adjusted life year (QALY) [ Designated as safety issue: No ]

Estimated Enrollment:	652
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To determine whether the use of a selective neck dissection (SEND) used electively on all patients presenting with stage I-II oral cavity squamous cell carcinoma (SCC) improves survival, disease-free survival, and loco-regional disease control rates.
To determine how SEND and complex reconstruction affect quality of life and mental health.
To determine whether the use of SEND on all patients presenting with stage I-II oral cavity SCC represents a cost-effective use of resources.

OUTLINE: This is a multicenter study. Patients are stratified by age (< 40 vs 40-64 vs ≥ 65 years of age), tumor stage (T1 vs T2), and surgeon.

Arm I: Patients undergo resection of the primary tumor with neck dissection.
Arm II: Patients undergo resection of the primary tumor alone. Patients complete the EORTC QLQ-C30, EORTC QLQ - H&N35, and the Hospital Anxiety and Depression Scale (HADS) before surgery and at 6, 12, and 24 months after surgery. Patients also complete the EQ-5D questionnaire at baseline, 6 months, 12 months, and 24 months. Additionally, a self-completion Health Service Use questionnaire is completed every 2 months, during the first 24 months after treatment, to enable costs to the NHS to be monitored.

After surgery, patients are followed periodically for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Patients with oral squamous cell carcinoma measuring 1 to 3 cm at the primary site
No clinical or preoperative imaging evidence of nodal involvement in the neck (N0)
Surgery is the primary mode of treatment
- Dose not need reconstruction that necessitates opening the neck, as assessed by the surgeon
No cancer of the lip
No prior head and neck tumor

PATIENT CHARACTERISTICS:

No technical, medical, or anaesthetic difficulties that preclude patients being entered into one of the trial arms
Not considered to be medically, socially, or psychiatrically unfit for surgery as first-line treatment by the multidisciplinary team
No other synchronous tumor
No preference for non-surgical treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571883

Locations

United Kingdom
Barnet General Hospital	Recruiting
Barnet, Hertfordshire, United Kingdom, EN5 3DJ
Contact: Contact Person 44-208-375-2098
United Kingdom, England
Cumberland Infirmary	Recruiting
Carlisle, England, United Kingdom, CA2 7HY
Contact: Contact Person 44-122-881-4222
Facial Surgery Research Foundation	Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Contact Person 44-207-601-7582
Pennine Acute Hospitals	Recruiting
Oldham, England, United Kingdom, OL1 2PN
Contact: Contact Person 44-161-720-2143
Northampton General Hospital NHS Trust	Recruiting
Northampton, England, United Kingdom, NN1 5BD
Contact: Contact Person 44-160-454-4579
Luton and Dunstable Hospital	Recruiting
Luton-Bedfordshire, England, United Kingdom, LU4 0DZ
Contact: Contact Person 44-158-249-7333
Portsmouth Oncology Centre at Saint Mary's Hospital	Recruiting
Portsmouth Hants, England, United Kingdom, PO3 6AD
Contact: Contact Person 44-239-228-6099
Queen's Medical Centre	Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Contact Person 44-115-924-9924 ext. 68915
Saint Bartholomew's Hospital	Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Contact Person 44-207-601-7582 send@savingfaces.info
Sunderland Royal Hospital	Recruiting
Sunderland, England, United Kingdom, SR4 7TP
Contact: Contact Person 44-191-569-9132
Torbay Hospital	Recruiting
Torquay, England, United Kingdom, TQ2 7AA
Contact: Contact Person 44-180-365-4834
United Kingdom, Scotland
Crosshouse Hospital	Recruiting
Kilmarnock, Scotland, United Kingdom, KA2 OBE
Contact: Contact Person 44-156-357-7488
Falkirk & District Royal Infirmary	Recruiting
Falkirk, Scotland, United Kingdom, FK1 5QE
Contact: Contact Person 44-132-461-6419

Sponsors and Collaborators

The Facial Surgery Research Foundation

Investigators

Study Chair:

Iain Hutchison

The Facial Surgery Research Foundation

More Information

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

Study ID Numbers:	CDR0000577728, FSRF-SEND-001, EU-20794
Study First Received:	December 11, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00571883
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity

Study placed in the following topic categories:

Squamous cell carcinoma
Mouth Neoplasms
Lip and oral cavity cancer
Dental Caries
Carcinoma
Epidermoid carcinoma
Oral squamous cell carcinoma

Head and Neck Neoplasms
Oral cancer
Neoplasm Metastasis
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 13, 2009