Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 11639 for:    Oral Cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03017053
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Chenping Zhang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Oral Cancer Radiation: Radiotherapy Procedure: Elective neck dissection Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor
Study Start Date : July 2016
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Experimental: Radiotherapy
Primary surgery & Radiotherapy
Radiation: Radiotherapy
Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor

Active Comparator: Elective neck dissection
Primary surgery & Elective neck dissection
Procedure: Elective neck dissection
Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor




Primary Outcome Measures :
  1. Neck control rates [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 1 year ]
  2. Disease-free survival [ Time Frame: 2 years ]
  3. Disease-free survival [ Time Frame: 3 years ]
  4. Disease-free survival [ Time Frame: 5 years ]
  5. Overall survival [ Time Frame: 3 years ]
  6. Overall survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017053


Contacts
Layout table for location contacts
Contact: Chenping ZHANG, Ph.D +86-21-63136856 zhang.chenping@hotmail.com

Locations
Layout table for location information
China
Shanghai Ninth People's Hospital Recruiting
Shanghai, China
Contact: Chenping ZHANG, Ph.D    +86-21-63136856    zhang.chenping@hotmail.com   
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
Layout table for investigator information
Principal Investigator: Chenping ZHANG, Ph.D Shanghai Ninth People's Hospital Shanghai, China, 200011

Layout table for additonal information
Responsible Party: Chenping Zhang, Principal Investigator,Head of Oral and Maxillofacial- Head and Neck Oncology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03017053     History of Changes
Other Study ID Numbers: 15411950300
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chenping Zhang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Neck dissection
Survival
Early oral cancer
Early oral cavity squamous cancer with node negative neck

Additional relevant MeSH terms:
Layout table for MeSH terms
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases