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Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma

Primary Purpose

Oral Squamous Cell Carcinoma, Neck Dissection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elective neck dissection
Therapeutic neck dissection
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven T1 or T2 N1 M0( AJCC 8th) squamous call carcinoma of tongue(except base of the tongue ), buccal mucosa, upper and lower gums, hard palate and floor of mouth; No history of chemotherapy, radiotherapy or targeted therapy,for any reason before No history of a prior malignancy in head and neck region No history of a prior malignancy outside head and neck region in the preceding 5 years Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1; Participants will be reliable for follow-up Understanding the protocol and is able to give informed consent Exclusion Criteria: failed to obtain the signed written informed consent; definite distant metastasis or other malignant tumor; Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy); previously received radiotherapy for primary tumors or lymph nodes; previously received anti-tumor biological targeted therapy; Chemotherapy or immunotherapy has been applied to the primary tumor in the past; Patients with any malignant tumor in the past 5 years (except the cured basal cell carcinoma of the skin or cervical carcinoma in situ)； Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction that occurred in the first 12 months, serious arrhythmia requiring medical treatment, liver, kidney or metabolic diseases); known human immunodeficiency virus (HIV) infection; chronic diseases requiring immune preparations or hormone treatment; pregnant or lactating women; drug/alcohol abuse, or suffering from psychological or mental diseases that may interfere with research compliance; Epilepsy patients who need medical treatment (such as steroids or antiepileptic drugs); participated in other clinical trials in the past 30 days; cases that the researcher thinks are not suitable for joining the group.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Elective neck dissection

    Therapeutic neck dissection

    Arm Description

    patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor

    Patient underwent therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor

    Outcomes

    Primary Outcome Measures

    Recurrence rate of neck
    From date of randomization until the date of metastasis of ipsilateral or contralateral cervical lymph nodes

    Secondary Outcome Measures

    Overall survival
    From date of randomization until the date of death from any cause

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    April 10, 2023
    Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05806073
    Brief Title
    Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma
    Official Title
    Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V". Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.
    Detailed Description
    There are controversies on the benefits of therapeutic neck dissection (I-V region) for clinically T1-2N1M0 oral squamous cell carcinoma(cT1-2N1M0). The aim of this study is to determine the need for a randomized controlled trial in order to evaluate the safety of elective neck dissection (I-III region) for patients of cT1-2N1M0. We initiate this study, expecting 188 primary oral cancer patients to be enrolled. And we are going to randomly divide these patients into two groups: "elective neck dissection (END)" and "therapeutic neck dissection (TND)". The END group will undergo one stage surgery of END and primary tumor excision, and the TND group will be treated with one stage surgery of TND and primary tumor excision. All patients will be followed up with at least 2 years after initial treatment, and the neck recurrence rate (primary outcome measures), postoperative complication rate, quality of life and survival between groups will be compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Squamous Cell Carcinoma, Neck Dissection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    188 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Elective neck dissection
    Arm Type
    Experimental
    Arm Description
    patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor
    Arm Title
    Therapeutic neck dissection
    Arm Type
    Experimental
    Arm Description
    Patient underwent therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor
    Intervention Type
    Procedure
    Intervention Name(s)
    Elective neck dissection
    Intervention Description
    patient underwent elective neck dissection(level I-III) as initial treatment, along with the excision of the primary tumor
    Intervention Type
    Procedure
    Intervention Name(s)
    Therapeutic neck dissection
    Intervention Description
    patient underwent Therapeutic neck dissection(level I-V) as initial treatment, along with the excision of the primary tumor
    Primary Outcome Measure Information:
    Title
    Recurrence rate of neck
    Description
    From date of randomization until the date of metastasis of ipsilateral or contralateral cervical lymph nodes
    Time Frame
    up to 2 year
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    From date of randomization until the date of death from any cause
    Time Frame
    up to 2 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically proven T1 or T2 N1 M0( AJCC 8th) squamous call carcinoma of tongue(except base of the tongue ), buccal mucosa, upper and lower gums, hard palate and floor of mouth; No history of chemotherapy, radiotherapy or targeted therapy,for any reason before No history of a prior malignancy in head and neck region No history of a prior malignancy outside head and neck region in the preceding 5 years Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1; Participants will be reliable for follow-up Understanding the protocol and is able to give informed consent Exclusion Criteria: failed to obtain the signed written informed consent; definite distant metastasis or other malignant tumor; Previous surgical operations for primary tumors or lymph nodes in the head and neck (except biopsy); previously received radiotherapy for primary tumors or lymph nodes; previously received anti-tumor biological targeted therapy; Chemotherapy or immunotherapy has been applied to the primary tumor in the past; Patients with any malignant tumor in the past 5 years (except the cured basal cell carcinoma of the skin or cervical carcinoma in situ)； Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that started in the last 3 months, congestive heart failure, myocardial infarction that occurred in the first 12 months, serious arrhythmia requiring medical treatment, liver, kidney or metabolic diseases); known human immunodeficiency virus (HIV) infection; chronic diseases requiring immune preparations or hormone treatment; pregnant or lactating women; drug/alcohol abuse, or suffering from psychological or mental diseases that may interfere with research compliance; Epilepsy patients who need medical treatment (such as steroids or antiepileptic drugs); participated in other clinical trials in the past 30 days; cases that the researcher thinks are not suitable for joining the group.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hong Zhen
    Phone
    +86-（021）23271699
    Ext
    5576
    Email
    hannannan111@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Min Ruan
    Phone
    +86-18717893527
    Email
    doctorruanmin@sjtu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma

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