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Trial Title:
Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma
NCT ID:
NCT05806073
Condition:
Oral Squamous Cell Carcinoma
Neck Dissection
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Elective neck dissection
Description:
patient underwent elective neck dissection(level I-III) as initial treatment, along with
the excision of the primary tumor
Arm group label:
Elective neck dissection
Intervention type:
Procedure
Intervention name:
Therapeutic neck dissection
Description:
patient underwent Therapeutic neck dissection(level I-V) as initial treatment, along with
the excision of the primary tumor
Arm group label:
Therapeutic neck dissection
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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;
2. No history of chemotherapy, radiotherapy or targeted therapy,for any reason before
3. No history of a prior malignancy in head and neck region
4. No history of a prior malignancy outside head and neck region in the preceding 5
years
5. Eastern Cooperative Oncology Group Performance score (ECOG PS) is 0 or 1;
6. Participants will be reliable for follow-up
7. Understanding the protocol and is able to give informed consent
Exclusion Criteria:
1. failed to obtain the signed written informed consent;
2. definite distant metastasis or other malignant tumor;
3. Previous surgical operations for primary tumors or lymph nodes in the head and neck
(except biopsy);
4. previously received radiotherapy for primary tumors or lymph nodes;
5. previously received anti-tumor biological targeted therapy;
6. Chemotherapy or immunotherapy has been applied to the primary tumor in the past;
7. Patients with any malignant tumor in the past 5 years (except the cured basal cell
carcinoma of the skin or cervical carcinoma in situ)；
8. 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);
9. known human immunodeficiency virus (HIV) infection;
10. chronic diseases requiring immune preparations or hormone treatment;
11. pregnant or lactating women;
12. drug/alcohol abuse, or suffering from psychological or mental diseases that may
interfere with research compliance;
13. Epilepsy patients who need medical treatment (such as steroids or antiepileptic
drugs);
14. participated in other clinical trials in the past 30 days;
15. cases that the researcher thinks are not suitable for joining the group.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Agency class:
Other
Source:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806073
