Clinical trial NCT02743832: A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Official title: A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Squamous Cell
Keywords: Oral squamous cell carcinoma
Tumor budding
Cervical lymph node dissection
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Second Affiliated Hospital, Sun Yat-Sen University
name: Hospital of Stomatology, Sun Yat-Sen University
First posted: 2016-04-19
Enrollment: 524
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Five-year survival rate
timeFrame: After the first year, review every three months at a time；The next four years, review every six months at a time.
measure: Disease free survival
timeFrame: After the first year, review every three months at a time；The next four years, review every six months at a time.
Secondary outcomes:
measure: Recurrence rate
timeFrame: After the first year, review every three months at a time；The next four years, review every six months at a time.
measure: Evaluation of quality of life
timeFrame: After the first year, review every three months at a time；The next four years, review every six months at a time.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University
name: Jinsong Hou, PhD
role: STUDY_DIRECTOR
References:
citation: Almangush A, Salo T, Hagstrom J, Leivo I. Tumour budding in head and neck squamous cell carcinoma - a systematic review. Histopathology. 2014 Nov;65(5):587-94. doi: 10.1111/his.12471. Epub 2014 Oct 6.
citation: Almangush A, Bello IO, Keski-Santti H, Makinen LK, Kauppila JH, Pukkila M, Hagstrom J, Laranne J, Tommola S, Nieminen O, Soini Y, Kosma VM, Koivunen P, Grenman R, Leivo I, Salo T. Depth of invasion, tumor budding, and worst pattern of invasion: prognostic indicators in early-stage oral tongue cancer. Head Neck. 2014 Jun;36(6):811-8. doi: 10.1002/hed.23380. Epub 2013 Sep 2.
citation: Da Sacco L, Masotti A. Recent insights and novel bioinformatics tools to understand the role of microRNAs binding to 5' untranslated region. Int J Mol Sci. 2012 Dec 27;14(1):480-95. doi: 10.3390/ijms14010480.
citation: Xie N, Wang C, Liu X, Li R, Hou J, Chen X, Huang H. Tumor budding correlates with occult cervical lymph node metastasis and poor prognosis in clinical early-stage tongue squamous cell carcinoma. J Oral Pathol Med. 2015 Apr;44(4):266-72. doi: 10.1111/jop.12242. Epub 2014 Aug 28.
citation: Hori Y, Kubota A, Yokose T, Furukawa M, Matsushita T, Takita M, Mitsunaga S, Mizoguchi N, Nonaka T, Nakayama Y, Oridate N. Predictive Significance of Tumor Depth and Budding for Late Lymph Node Metastases in Patients with Clinical N0 Early Oral Tongue Carcinoma. Head Neck Pathol. 2017 Dec;11(4):477-486. doi: 10.1007/s12105-017-0814-1. Epub 2017 Apr 3.