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The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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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 groupTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: Radiotherapy
Primary surgery & Radiotherapy
Active Comparator: Elective neck dissection
Primary surgery & Elective neck dissection
Interventions
Radiation: - Radiotherapy
Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Procedure: - Elective neck dissection
Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
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International Sites
Status
Recruiting
Address
Shanghai Ninth People's Hospital
Shanghai, ,
Site Contact
Chenping ZHANG, Ph.D
[email protected]
+86-21-63136856
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