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Clinical trialNCT02089204UnknownObservational

Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal Carcinoma

SponsorXuzhou Medical UniversityEnrollment300Nasopharyngeal Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies in terms of its epidemiology, pathology, and treatment outcome . It is endemic in China and is one of the major public health problems. Concurrent radiotherapy and chemotherapy is the primary treatment for patients with NPC. Despite such aggressive treatment, many patients with locally advanced NPC still develop locally recurrent disease. Since local control is directly related to patient morbidity and mortality in NPC, there is a strong need to identify methods to further improve treatment outcome for NPC. One strategy to improve local control is to escalate the dose of radiotherapy. This is because local control has been shown to be directly related to the radiotherapy dose. Several different techniques, including brachytherapy, stereotactic radiosurgery, and dose-painting intensity modulated radiotherapy (IMRT), have been used to increase radiotherapy dose. However, due to the large number of critical anatomic structures near the nasopharynx, dose-escalation in NPC can also lead to increased toxicities. One technique that has achieved dose-escalation with minimal increase in toxicity is simultaneous modulated accelerated radiation therapy (SMART). The main challenge for such treatment is to identify the appropriate tumor volume to receive the high-dose radiotherapy. Conventional dose-escalation is conducted using computed tomography (CT) to identify the gross tumor volume (GTV). However, recent progress with F-18 fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) in treatment planning allows more accurate tumor volume delineation. We hypothesize that the use of PET/CT in treatment planning can improve dose-escalation radiotherapy for NPC which in turn can improve therapeutic efficacy while reducing toxicity. PET/CT imaging of tissue hypoxia using \[F-18\]fluoromisonidazole (FMISO), the most widely used nitroimidazole imaging agent.Given that there has been no clinical trials directly comparing conventional chemoradiotherapy to CT-guided dose-escalation chemoradiotherapy or PET/CT guided dose-escalation chemoradiotherapy in locally advanced NPC.This was a study to evaluate the role of FMISO-PET hypoxia imaging for predicting survival in NPC,our study aims to compare the local control, overall survival and toxicities of the three treatment regimens..

Investigators

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Sites

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Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2010
Primary completion
28 Feb 2014
Completion
31 Dec 2015
Last update posted
17 Mar 2014
Registered enrollment
300
Registry id
NCT02089204

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.