Brief Title
The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
Official Title
The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
Brief 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.
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Neck control rates
Secondary Outcome
Disease-free survival
Condition
Oral Cancer
Intervention
Radiotherapy
Study Arms / Comparison Groups
Radiotherapy
Description: Primary surgery & Radiotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
270
Start Date
July 2016
Completion Date
July 2025
Primary Completion Date
July 2025
Eligibility Criteria
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Chenping ZHANG, Ph.D, +86-21-63136856, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03017053
Organization ID
15411950300
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Sponsor
Chenping ZHANG, Ph.D, Principal Investigator, Shanghai Ninth People's Hospital Shanghai, China, 200011
Verification Date
January 2017