Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients

Zhongnan Hospital

Status and phase: Unknown; Phase 2

Conditions: Radiotherapy; Complications; Oral Cancer

Treatments: Device: PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03008694

ZhongnanH

Details and patient eligibility

About

This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol

Full description

Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed oral squamous-cell carcinoma
• Age > 17 years
• Signed informed consent
• ECOG Performance status 0-2
• Must be able to start RT within 4 weeks after PET/CT simulation

Exclusion criteria

• stage IV disease diagnosed before acquisition of staging PET/CT
• prior radiotherapy to oral and neck
• Unable to understand study participation
• Claustrophobia
• pregnant or breast feeding mothers

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

1

Experimental group

Description:

PET/CT

Treatment:

Device: PET/CT