Clinical Trial: Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma—A Prospective Multicenter Randomized Controlled Study

Brief Summary: Controversy over surgical treatment of clinically negative neck in early stage oral squamous cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the subject of clinical debate. Currently the clinically negative patients are treated by one of the two main policies: one is elective neck dissection; the other is "watchful waiting". The objective of this multi-institutional prospective randomized controlled study is to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be randomized into two groups: elective neck dissection versus watch and wait. The survival rate and the recurrence rate between two groups will be compared. The result of the study will give surgeons evidence-based instructions for the management of clinically negative neck in patients with cancer of oral cavity.

Detailed Summary: There are controversies on the benefits of elective neck dissection (END) for clinically negative neck in early stage oral squamous cell carcinoma. The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. We initiate this multi-institutional study, expecting 448 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: END and "watch and wait". The END group will undergo one stage surgery of END and primary tumor excision, and the "watch and wait"group will be treated with primary tumor excision transorally as initial treatment, with rigorous postoperation consultation. All patients will be followed up with at least 5 years after initial treatment, and the survival rate and the recurrence rate between groups will be compared.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy [ Time Frame: 5 years ]

The 5-year's survival and the disease free survival of the two group of patients are being measured and compared with one and other, so the survival benefit of the two policy is evaluated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Does END have the equal or lower recurrence rate to the wait and watch policy [ Time Frame: 5 years ]
    The recurrence includes recurrence of the primary tumor and the neck, and it's measured by clinical examination, MRI examination and ultrasonic inspection.
  • quality of life [ Time Frame: 5 years ]
    The quality of life of patients after surgery is measured by UW-QOL.


Original Secondary Outcome:

  • Is END has the equal or lower recurrence rate to the wait and watch policy [ Time Frame: 5 years ]
    The recurrence includes recurrence of the primary tumor and the neck, and it's measured by clinacal examination, MRI examination and ultrasonic inspection.
  • quality of live [ Time Frame: 5 years ]
    The quality of live of patients after surgery is measrued by UW-QOL.


Information By: Sun Yat-sen University

Dates:
Date Received: April 6, 2011
Date Started: April 2011
Date Completion: December 2021
Last Updated: April 9, 2015
Last Verified: April 2015