Back to resultsThe Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
Primary Purpose
Oral Cancer
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Elective neck dissection
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cancer focused on measuring Neck dissection, Survival, Early oral cancer, Early oral cavity squamous cancer with node negative neck
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- The patient has participated in other experimental therapy studies within 30 days
- Researchers believe that the situation is unsuitable for participation in the group
Sites / Locations
- Shanghai Ninth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radiotherapy
Elective neck dissection
Arm Description
Primary surgery & Radiotherapy
Primary surgery & Elective neck dissection
Outcomes
Primary Outcome Measures
Neck control rates
Secondary Outcome Measures
Disease-free survival
Disease-free survival
Disease-free survival
Disease-free survival
Overall survival
Overall survival
Full Information
NCT ID
NCT03017053
First Posted
January 9, 2017
Last Updated
January 9, 2017
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT03017053
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
Neck dissection, Survival, Early oral cancer, Early oral cavity squamous cancer with node negative neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
Primary surgery & Radiotherapy
Arm Title
Elective neck dissection
Arm Type
Active Comparator
Arm Description
Primary surgery & Elective neck dissection
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Intervention Type
Procedure
Intervention Name(s)
Elective neck dissection
Intervention Description
Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
Primary Outcome Measure Information:
Title
Neck control rates
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
1 year
Title
Disease-free survival
Time Frame
2 years
Title
Disease-free survival
Time Frame
3 years
Title
Disease-free survival
Time Frame
5 years
Title
Overall survival
Time Frame
3 years
Title
Overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
The patient has participated in other experimental therapy studies within 30 days
Researchers believe that the situation is unsuitable for participation in the group
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenping ZHANG, Ph.D
Phone
+86-21-63136856
Email
zhang.chenping@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenping ZHANG, Ph.D
Organizational Affiliation
Shanghai Ninth People's Hospital Shanghai, China, 200011
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenping ZHANG, Ph.D
Phone
+86-21-63136856
Email
zhang.chenping@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
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