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

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03017053
• Other study ID #: 15411950300
• Status: Recruiting
• Phase: Phase 4
• First received: January 9, 2017
• Last updated: January 9, 2017
• Start date: July 2016
• Est. completion date: July 2025

Study information

• Verified date: January 2017
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Chenping ZHANG, Ph.D
• Phone: +86-21-63136856
• Email: zhang.chenping[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck control rates		2 years	No
Secondary	Disease-free survival		1 year	No
Secondary	Disease-free survival		2 years	No
Secondary	Disease-free survival		3 years	No
Secondary	Disease-free survival		5 years	No
Secondary	Overall survival		3 years	No
Secondary	Overall survival		5 years	No