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

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 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

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