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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


N/A
16 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Iain Hutchison

Investigator Role:

Study Chair

Investigator Affiliation:

The Facial Surgery Research Foundation

Authority:

Unspecified

Study ID:

CDR0000577728

NCT ID:

NCT00571883

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • tongue cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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