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

Phase 2

• Conditions: Oral Cancer; Radiotherapy; Complications
• Interventions: Device: PET/CT

• Registration Number: NCT03008694
• Lead Sponsor: Zhongnan Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PET/CT	PET/CT

Primary Outcome Measures

Name	Time	Method
progress free survival	baseline to 2 years