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

• Sponsor: Zhongnan Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03008694
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Duration (Months): 24

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer; Radiotherapy; Complications	Device: PET/CT	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 PET/CT	Device: PET/CT; pet/ct is used as radiotherapy simulation

Outcome Measures

Primary Outcome Measures

1. progress free survival [baseline to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhongnan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: yahua zhong, Director,oncology , Principal Investigator, Clinical Professor, Zhongnan Hospital
• ClinicalTrials.gov Identifier: NCT03008694
• Other Study ID Numbers: ZhongnanH
• First Posted: Jan 2, 2017
• Last Update Posted: Jan 2, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by yahua zhong, Director,oncology , Principal Investigator, Clinical Professor, Zhongnan Hospital: PET/CT
• Additional relevant MeSH terms: Mouth Neoplasms

Study Results

No Results Posted as of Jan 2, 2017