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NCT03008694 Clinical Trial

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

Oral Cancer Clinical Trial

Official title:
Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03008694
Other study ID # ZhongnanH
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received December 23, 2016
Last updated December 29, 2016
Start date January 2017
Est. completion date January 2019

Study information
Verified date December 2016
Source Zhongnan Hospital
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Hubei Province
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date January 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• PET/CT
pet/ct is used as radiotherapy simulation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhongnan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary progress free survival baseline to 2 years No
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