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

NCT ID: NCT03017053

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2025-07-31

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.

Conditions

Oral Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy

Primary surgery \& Radiotherapy

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Elective neck dissection

Primary surgery \& Elective neck dissection

Group Type: ACTIVE_COMPARATOR

Elective neck dissection

Intervention Type: PROCEDURE

Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Interventions

Radiotherapy

Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Intervention Type: RADIATION

Elective neck dissection

Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Chenping Zhang

Principal Investigator,Head of Oral and Maxillofacial- Head and Neck Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chenping ZHANG, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Shanghai, China, 200011

Locations

Shanghai Ninth People's Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chenping ZHANG, Ph.D

Role: CONTACT

zhang.chenping@hotmail.com

+86-21-63136856

Facility Contacts

Chenping ZHANG, Ph.D

Role: primary

zhang.chenping@hotmail.com

+86-21-63136856

Other Identifiers

15411950300

Identifier Type: -

Identifier Source: org_study_id