The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor

  • STATUS
    Recruiting
  • End date
    Jul 21, 2025
  • participants needed
    270
  • sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Updated on 24 February 2022
carcinoma
metastasis
oral cancer
neck dissection

Summary

Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.

Description

Objective: To evaluate the effect of radiotherapy on the neck of early oral cancer with poor pathologic factors.

This is a randomized, prospective, open, multicenter study. Intervention: Patients receive primary tumor resection followed by radiotherapy.

Control: Patients receive primary tumor resection with selective neck dissection.

Primary

2 years neck control rates

Secondary

Disease-free survival (1, 2, 3, 5 years) Overall survival (3, 5 years) Quality of life

Endpoint definition:

1 year, 2 years, 3 years, 5 years disease-free survival is defined as: patients proportion from the date of surgery completion to 1 year, 2 years, 3 years, 5 years did not find clear evidence of recurrence or metastasis.

3 years, 5 years overall survival is defined as: the proportion of patients who survived from the beginning of the study to the third and fifth year in the total enrollment.

Details
Condition Oral Cancer
Treatment Radiotherapy, elective neck dissection
Clinical Study IdentifierNCT03017053
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
Age 18 and 75 years
Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment
In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
KPS 70
Normal bone marrow reserve function and normal liver, kidney function
Expected survival period 6 months

Exclusion Criteria

Inability to provide an informed consent
Evidence of oral distant metastasis or other malignancies
The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
Prior radiotherapy for primary tumor
The patient has previously received anti-tumor biological targeted therapy
The patient has received chemotherapy or immunotherapy for primary tumors
Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
With 3-4 grad Allergy to any drug in the treatment
Peripheral neuropathy> 1 grade
Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)
HIV positive
Chronic diseases requiring immune agents or hormone therapy
Pregnant or lactating women
Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)
The patient has participated in other experimental therapy studies within 30 days
Researchers believe that the situation is unsuitable for participation in the group
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note