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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Procedure: Elective neck dissection

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chenping ZHANG, Ph.D; Phone Number: +86-21-63136856; Email: zhang.chenping@hotmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital
    • Contact: Chenping ZHANG, Ph.D; Phone Number: +86-21-63136856; Email: zhang.chenping@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document
2. Age≥ 18 and≤ 75 years
3. 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
4. In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
5. KPS≥ 70
6. Normal bone marrow reserve function and normal liver, kidney function
7. Expected survival period≥ 6 months

Exclusion Criteria:

1. Inability to provide an informed consent
2. Evidence of oral distant metastasis or other malignancies
3. The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
4. Prior radiotherapy for primary tumor
5. The patient has previously received anti-tumor biological targeted therapy
6. The patient has received chemotherapy or immunotherapy for primary tumors
7. Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
8. With 3-4 grad Allergy to any drug in the treatment
9. Peripheral neuropathy> 1 grade
10. 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)
11. HIV positive
12. Chronic diseases requiring immune agents or hormone therapy
13. Pregnant or lactating women
14. Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
15. Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)
16. The patient has participated in other experimental therapy studies within 30 days
17. Researchers believe that the situation is unsuitable for participation in the group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy; Primary surgery & Radiotherapy	Radiation: Radiotherapy; Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Active Comparator: Elective neck dissection; Primary surgery & Elective neck dissection	Procedure: Elective neck dissection; Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neck control rates	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Overall survival	3 years
Disease-free survival	3 years
Disease-free survival	5 years
Disease-free survival	2 years
Disease-free survival	1 year

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Chenping ZHANG, Ph.D, Shanghai Ninth People's Hospital Shanghai, China, 200011

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Survival; Neck dissection; Early oral cavity squamous cancer with node negative neck; Early oral cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Neoplasms; Lip Neoplasms
• Other Study ID Numbers: 15411950300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO