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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Sun Yat-sen University
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Gui-Qing Liao, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01334320
First received: April 6, 2011
Last updated: November 26, 2011
Last verified: November 2011
  Purpose

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 would 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.


Condition Intervention
Oral Squamous Cell Carcinoma
Procedure: elective neck dissection
Procedure: watch and wait

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Survival Benefit of Elective Neck Dissection for Patients With T1,2N0M0 Oral Squamous Cell Carcinoma—A Prospective Multicenter Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Whether elective neck dissection (END) has equal or higher survival rate to the wait and watch policy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Does END have the equal or lower recurrence rate to the wait and watch policy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 life [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The quality of life of patients after surgery is measured by UW-QOL.


Estimated Enrollment: 448
Study Start Date: April 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: elective neck dissection Procedure: elective neck dissection
patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor
Other Name: superior omohyoid neck dissection, SOHND
No Intervention: wait and see Procedure: watch and wait
at the first time of surgery, no intervention of the neck is taken, but with close monitoring, once the sign of metastasis appears, therapeutic neck dissection is to be taken
Other Names:
  • wait and see
  • watchful waiting

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age:20 to 70 years old, both male and female
  2. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the oral tongue, buccal mucosa, gingiva, floor of mouth, and hard palate
  3. The maximum diameter of the primary tumor is less than 4cm
  4. Clinical nodal staging has been confirmed negative via both clinical examination and imaging (MRI or lateral and central neck ultrasound)
  5. With at least 1-year's expected survival time
  6. Willing to join the protocol and is able to give written informed consent

Exclusion Criteria:

  1. Patient with severe cardiac insufficiency, hepatic insufficiency, renal insufficiency, of systemic infection diseases
  2. The patient is pregnant or lactating
  3. Patients with a history of surgical treatment, radiotherapy, chemotherapy, biotherapy and targeted therapy, et al, before participating in the study
  4. Patient is currently participating in another investigational drug study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334320

Contacts
Contact: Guiqing Liao, MD, DDS 86-20-83862531 drliaoguiqing@hotmail.com

Locations
China, Guangdong
Hospital of Stomatology, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510055
Contact: Guiqing Liao, MD,DDS    86-20-83862531    drliaoguiqing@hotmail.com   
Principal Investigator: Guiqing Liao, MD,DDS         
Sub-Investigator: Yuantao Hao, PhD         
Sub-Investigator: Yuxiong Su, MD,DDS         
Cancer Center, Sun Yat-Sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhuming Guo, MD    86-20-33181550    guozhm@mail.sysu.edu.cn   
Principal Investigator: Zhuming Guo, MD         
The First Affiliated Hospital, Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Chongjin Feng, PhD    86-20-87332200 ext 8414    drfcj@yahoo.com.cn   
Principal Investigator: Chongjin Feng, MD,DDS         
Sun Yat-sen Memorial Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jinsong Li, PhD    86-20-81332429    lijinsong1967@163.com   
Principal Investigator: Jinsong Li, MD,DDS         
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Principal Investigator: Guiqing Liao, MD, DDS Sun Yat-sen University
  More Information

Additional Information:
Publications:
Responsible Party: Gui-Qing Liao, Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01334320     History of Changes
Other Study ID Numbers: 2010018
Study First Received: April 6, 2011
Last Updated: November 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
oral squamous cell carcinoma
elective neck dissection
"watchful waiting"
survival benefit
recurrence rate

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on July 22, 2014