Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03727594
  4. Details
NCT03727594 Clinical Trial

Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:
Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03727594
Other study ID # 151099
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date January 2021

Study information
Verified date October 2018
Source University Hospital of Ferrara
Contact Nicola Malagutti, MD
Phone +393339011406
Email nicolamalagutti@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2021
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- accepted informed consent

- preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma

- patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)

Exclusion Criteria:

- rejected informed consent

- patients not fit to surgery (according to the general health condition and the clinical tumor stage)

- pregnant women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy University Hospital of Ferrara Ferrara

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy 5 years
Primary Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins 5 years
Primary Overall survival Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes. 5 years
Primary Disease-free survival Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes. 5 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06174428 - Validity of Viome's Oral/Throat Cancer Test
Recruiting NCT05098119 - Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002) Phase 2
Suspended NCT03952585 - De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer Phase 2/Phase 3
Terminated NCT03618134 - Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner Phase 1/Phase 2
Recruiting NCT03421470 - Docetaxel and Radiation Therapy in Treating Patients With HPV Positive Oropharynx Cancer Phase 3
Completed NCT06314711 - Ex Vivo 3D-ultrasound for Oropharyngeal Cancer N/A
Completed NCT04572100 - Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer Phase 1
Not yet recruiting NCT06055868 - People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity
Recruiting NCT05522881 - The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan
Recruiting NCT04222543 - Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging Phase 2
Recruiting NCT04564989 - Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Active, not recruiting NCT04965792 - Post-treatment Surveillance in HPV+ Oropharyngeal SCC
Recruiting NCT06356272 - Oropharynx (OPX) Biomarker Trial
Active, not recruiting NCT01874171 - Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC Phase 3
Recruiting NCT05333523 - Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study. Phase 3
Completed NCT03618654 - Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma Early Phase 1
Recruiting NCT04801472 - Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM) N/A
Active, not recruiting NCT03410615 - Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC Phase 2
Recruiting NCT05268614 - Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma Phase 2
Not yet recruiting NCT05582590 - Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers Phase 1