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

ConditionCarcinoma, Squamous Cell
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorJinsong Hou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Han race;

Oral squamous cell carcinoma is confirmed by pathology;

The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;

The primary lesion is no more than 4cm;

Disqualifiers

Do not meet the inclusion criteria;

The primary lesion is more than 4cm or invade adjacent tissues;

Do not review on schedule;

Patients receive not only surgical procedures, but other antineoplastic treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resection for primary lesion and cervical lymph node dissection

    Procedure/Surgery

    Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.

  • Resection for primary lesion only

    Procedure/Surgery

    Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.

Treatment groups

524 Participants
are divided into 4 treatment groups
Group A: High-level tumor budding group with CLNDExperimental treatment 1 intervention
Group B: High-level tumor budding group without CLNDExperimental treatment 1 intervention
Group C: Low-level tumor budding group with CLNDExperimental treatment 1 intervention
Group D: Low-level tumor budding group without CLNDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Five-year survival rate

The time from the first operation to death was recorded

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

Disease free survival

The time from the start of surgery to the discovery of the first cervical lymphatic metastases

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 outcomes

1

Recurrence rate

To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.

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

Evaluation of quality of life

Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.

Time frame
After the first year, review every three months at a time；The next four years, review every six months at a time.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinsong Hou

Lead sponsor

Sun Yat-sen University

Sponsor institution

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Second Affiliated Hospital, Sun Yat-Sen University

Collaborator

Hospital of Stomatology, Sun Yat-Sen University

Collaborator

Source ClinicalTrials.gov
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