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A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743832
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : April 21, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Information provided by (Responsible Party):
Jinsong Hou, Sun Yat-sen University

Brief Summary:
The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Procedure: Resection for primary lesion and cervical lymph node dissection Procedure: Resection for primary lesion Not Applicable

Detailed Description:
Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized,Multicenter,Prospectie,Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Study Start Date : July 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection(CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
Procedure: Resection for primary lesion and cervical lymph node dissection
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.

Active Comparator: High-level group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
Procedure: Resection for primary lesion
Resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.

Experimental: Low-level group with CLND
Resection for primary lesion and cervical lymph node dissection(CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
Procedure: Resection for primary lesion and cervical lymph node dissection
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.

Active Comparator: Low-level group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
Procedure: Resection for primary lesion
Resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.




Primary Outcome Measures :
  1. Five-year survival rate [ Time Frame: After the first year, review every three months at a time;The next four years, review every six months at a time. ]

Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: After the first year, review every three months at a time;The next four years, review every six months at a time. ]
  2. Quality Of Life [ Time Frame: After the first year, review every three months at a time;The next four years, review every six months at a time. ]
  3. Disease-free survival [ Time Frame: After the first year, review every three months at a time;The next four years, review every six months at a time. ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Han race;
  2. Oral squamous cell carcinoma is confirmed by pathology;
  3. The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa, gingiva, mouth floor, hard palate mucosa;
  4. The primary lesion is no more than 4cm;
  5. Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
  6. Patients and families agree to participate in the study;
  7. Patients do not have cognitive disorders.

Exclusion Criteria:

  1. Do not meet the inclusion criteria;
  2. The primary lesion is more than 4cm or invade adjacent tissues;
  3. Do not review on schedule;
  4. Patients receive not only surgical procedures, but other antineoplastic treatment;
  5. There are serious adverse events after operation;
  6. Patients quit the study voluntarily;
  7. Patients quit the study because of physical condition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743832


Contacts
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Contact: Jinsong Hou, PhD 86-13825141651 houjsgz@aliyun.com
Contact: Cheng Wang, PhD 86-13760853366 drwangcheng@outlook.com

Locations
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China, Guangdong
Guanghua School of Stomatolagy, Hospital of Stomatolagy Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510055
Contact: Jinsong Hou, PhD    86-13825141651    houjsgz@aliyun.com   
Contact: Cheng Wang, PhD    86-13760853366    drwangcheng@outlook.com   
Sponsors and Collaborators
Jinsong Hou
First Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Investigators
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Study Director: Jinsong Hou, PhD Guanghua School of Stomatolagy, Hospital of Stomatolagy Sun Yat-sen University

Publications of Results:
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Responsible Party: Jinsong Hou, Vice Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02743832    
Other Study ID Numbers: HouJ-2015018
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by Jinsong Hou, Sun Yat-sen University:
Surgery, Oral
Tumor budding
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell