Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal Carcinoma

NCT02089204 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2014-03-17

No results posted yet for this study

Summary

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..

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

FMISO-PET/CT

Fluorine-18-labeled fluoromisonidazole PET/CT-guided dose escalation chemoradiotherapy (group C). Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy.

RADIATION

FDG-PET/CT

18F-FDG PET/CT -guided dose escalation chemoradiotherapy. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy.

RADIATION

contrast-enhanced CT

contrast-enhanced CT -guided dose escalation chemoradiotherapy. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • Xuzhou Medical University

    lead OTHER

Principal Investigators

  • ZHANG Longzhen, MD · Xuzhou Medical University

  • Wang Andrew Z., MD and PHD · University of North Carolina at Chapel Hill, USA

  • Wang Jianshe, M.M. · Xuzhou Medical University

  • Xin Yong, M.M. · Xuzhou Medical University

  • Xu Kai, MD · Xuzhou Medical University

  • Tang Tianyou, M.M. · Xuzhou Medical University

  • Ding Xin, M.M. · Xuzhou Medical University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-02-28
Completion
2015-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02089204 on ClinicalTrials.gov