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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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