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

NCT03017053 | Unknown Phase 4

• 1 other identifier: 15411950300
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer

Keywords

Neck dissection; Survival; Early oral cancer; Early oral cavity squamous cancer with node negative neck

Outcome Measures

Primary Outcomes (1)

• Neck control rates

  2 years

Secondary Outcomes (6)

• Disease-free survival

  1 year

• Disease-free survival

  2 years

• Disease-free survival

  3 years

• Disease-free survival

  5 years

• Overall survival

  3 years

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Primary surgery \& Radiotherapy

Radiation: Radiotherapy

Elective neck dissection

ACTIVE COMPARATOR

Primary surgery \& Elective neck dissection

Procedure: Elective neck dissection

Interventions

Radiotherapy RADIATION

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

Radiotherapy

Elective neck dissection PROCEDURE

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

Elective neck dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• Age≥ 18 and≤ 75 years
• 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
• In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection
• KPS≥ 70
• Normal bone marrow reserve function and normal liver, kidney function
• Expected survival period≥ 6 months

You may not qualify if:

• Inability to provide an informed consent
• Evidence of oral distant metastasis or other malignancies
• The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )
• Prior radiotherapy for primary tumor
• The patient has previously received anti-tumor biological targeted therapy
• The patient has received chemotherapy or immunotherapy for primary tumors
• Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)
• With 3-4 grad Allergy to any drug in the treatment
• Peripheral neuropathy\> 1 grade
• 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)
• HIV positive
• Chronic diseases requiring immune agents or hormone therapy
• Pregnant or lactating women
• Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study
• Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chenping ZHANG, Ph.D

  Shanghai Ninth People's Hospital Shanghai, China, 200011

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenping ZHANG, Ph.D

CONTACT

+86-21-63136856; zhang.chenping@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Head of Oral and Maxillofacial- Head and Neck Oncology

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)