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

Learn more about:
Related Clinical Trial
Oral Microbioma and Oral Malignant Disease Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer. Radial Forearm Donor Site Closure Oral Cancer Awareness in Egypt Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line Mandibular Reconstruction Preplanning (ViPMR) the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients Newer Therapeutic Targets in Head and Neck Cancers Lateral Arm Free Flap for Reconstruction of the Oral Cavity and Head and Neck Soft Tissue Defects. Improved Implant for Reconstruction Purposes After Mandibular Resection Cell-free Tumor DNA in Head and Neck Cancer Patients Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions The Oral Microbiome in OSCC The Link Between Periodontitis, Smoking and Oral Cancer Research on Optimization and Evaluation of Oral Cancer Screening Methods Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings Topical Aldara (Imiquimod) for Oral Cancer Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions LLL Phototherapy in Oral Lesions Resulting From Anti-neoplastic Treatment Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survival Trial Understanding Non-radiotherapy-based Development of Trismus Use of Ultrasound for Measuring Size of Oral Tongue Cancers Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients Oral Cancer Screening and Education in Hong Kong Evaluating Oral Visual Inspection in the Control of Oral Cancer Inductive Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients Effects of EMG Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection: a Randomized Clinical Trial Prevention of Oral DNA Damage by Black Raspberries Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma NBI in Oral Cavity Cancer Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer Physical Activities by Technology Help (PATH) Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients Patient Evaluation for Head and Neck Surgery Branch Studies Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy Prospective Analysis of Robot-Assisted Surgery Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer Cigarette Smoking and Oral Microbiota Rapamycin Therapy in Head and Neck Squamous Cell Carcinoma Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line The Role of Lymphangiogenesis in Head and Neck Cancer Metastasis Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. MSOT Using Cetuximab-800CW for Detection of Cervical Lymph Node Metastases Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis Least Invasive Nonlinear Light Microscopy Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients Improving Access to Control of Diseases for Women IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Submandibular Gland Preservation in Neck Dissection uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression The Use of Functional Confections in Promoting Oral Health The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions Wild Type p53 Adenovirus for Oral Premalignancies Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Trial of IIb Preserving Neck Dissection Expression of Hypoxia-Inducible Factor-α in Oral Precancers and Cancers Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography Innovative Approach to Triage Oral Precancer The Role of SDF-1/CXCR4 in Metastasis of Oral Squamous Cell Carcinoma Rehabilitation Outcomes in Head and Neck Survivors Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions The Relation of Microtubule-Associated Protein 2 and Cell Migration Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study) Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue Oral Pathology Asynchronous Telementoring Pilot Study Polarized Reflectance Spectroscopy for Oral Lesions A Study of the Effects of PEITC on Oral Cells With Mutant p53 Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma The Role of microRNA-29b in the Oral Squamous Cell Carcinoma Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer – COOLS TRIAL Assessment of Mandibular Bone Invasion With MRI Using SWIFT Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients Epstein-Barr Detection in Oral Cancer Workplace Tobacco Cessation And Oral Cancer Screening Study Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer. Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies Effects of Mouth-opening Training on the Maximum Interincisal Opening Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy – 3-years Prospective Study Erlotinib Prevention of Oral Cancer (EPOC) Oral Cancer Screening in Mumbai, India by Primary Health Care Workers Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor. The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer. Validation of DNA Methylation Biomarkers for Oral Cancer Detection Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention Expression of VEGF-C and VEGF-CR in Oral Cancers and Premalignant Lesions PET/CT and Sentinel Node in Oral Cancer Validation of DNA Methylation Biomarkers for Oral Cancer Detection Web-based Education on Oral Cancer for Primary Care Physicians in Ohio Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients Using an APP in Post Oral Cancer Surgery to Affect Patients’ Needs and Quality of Life.

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 Information


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

Administrative Informations


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