Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal Carcinoma
Clinical Feasibility Study of Hypoxia Imaging -Guided IMRT on the Individualized Radiotherapy of Nasopharyngeal Carcinoma
1 other identifier
observational
300
0 countries
N/A
Brief 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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 9, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 17, 2014
March 1, 2014
3.7 years
March 9, 2014
March 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
local progression-free (LPF) survival rates
LPF was defined as the time from the date of radiotherapy to local progression in the five years after treatment.Durations were calculated from the end of treatment.
5 years
Secondary Outcomes (2)
disease-free survival (DFS)
5 years
overall survival (OS)
5 years
Other Outcomes (2)
acute toxicities
from treatment start to 4 weeks post-treatment
Late toxicities
from 4 weeks post-treatment to 5 years.
Study Arms (3)
FMISO-PET/CT
18F-MISO PET/CT -guided dose escalation chemoradiotherapy. All patients were given concurrent chemoradiotherapy within two weeks of diagnosis. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) IMRT technique in the dose-escalation treatment arms. Concurrent chemotherapy consisted of cisplatin (20mg / m2 ,iv, d1- 4) and docetaxel (75mg / m2, d1, d8) administered on the 1st and 4th week of treatment. All patients received adjuvant chemotherapy that ranged from 2 to 4 cycles.
FDG-PET/CT
18F-FDG PET/CT -guided dose escalation chemoradiotherapy. All patients were given concurrent chemoradiotherapy within two weeks of diagnosis. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) IMRT technique in the dose-escalation treatment arms. Concurrent chemotherapy consisted of cisplatin (20mg / m2 ,iv, d1- 4) and docetaxel (75mg / m2, d1, d8) administered on the 1st and 4th week of treatment. All patients received adjuvant chemotherapy that ranged from 2 to 4 cycles.
contrast-enhanced CT
contrast-enhanced CT -guided dose escalation chemoradiotherapy . GTVs were delineated based on fusing diagnostic CT images with simulation CT images.All patients were given concurrent chemoradiotherapy within two weeks of diagnosis. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) IMRT technique in the dose-escalation treatment arms. Concurrent chemotherapy consisted of cisplatin (20mg / m2 ,iv, d1- 4) and docetaxel (75mg / m2, d1, d8) administered on the 1st and 4th week of treatment. All patients received adjuvant chemotherapy that ranged from 2 to 4 cycles.
Interventions
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.
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.
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
Eligibility Criteria
Between June 2010 to June 2015, patients from Department of Radiation Oncology, Affiliated Hospital of Xuzhou Medical College.
You may qualify if:
- histologically confirmed NPC by biopsy,
- no evidence of distant metastasis,
- no previous treatment for NPC,
- Stages III\~IVA (AJCC 7th Edition) of locally advanced ,
- adequate liver function (albumin ≥30 g/L),
- adequate renal function (creatinine ≤100μmol/L) ,
- adequate bone marrow function(white blood count ≥ 4.0×109/L, platelets ≥ 100×109/L),
- Karnofsky performance status≥70,
You may not qualify if:
- Patients younger than 18,
- those with a prior (within 5 years) or synchronous malignancy were excluded.
- presence of distant metastases,
- pregnancy or lactation,
- other concomitant malignant disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wang J, Zheng J, Tang T, Zhu F, Yao Y, Xu J, Wang AZ, Zhang L. A Randomized Pilot Trial Comparing Position Emission Tomography (PET)-Guided Dose Escalation Radiotherapy to Conventional Radiotherapy in Chemoradiotherapy Treatment of Locally Advanced Nasopharyngeal Carcinoma. PLoS One. 2015 Apr 27;10(4):e0124018. doi: 10.1371/journal.pone.0124018. eCollection 2015.
PMID: 25915944DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ZHANG Longzhen, MD
Xuzhou Medical University
- STUDY DIRECTOR
Wang Andrew Z., MD and PHD
University of North Carolina at Chapel Hill, USA
- PRINCIPAL INVESTIGATOR
Wang Jianshe, M.M.
Xuzhou Medical University
- PRINCIPAL INVESTIGATOR
Xin Yong, M.M.
Xuzhou Medical University
- PRINCIPAL INVESTIGATOR
Xu Kai, MD
Xuzhou Medical University
- PRINCIPAL INVESTIGATOR
Tang Tianyou, M.M.
Xuzhou Medical University
- PRINCIPAL INVESTIGATOR
Ding Xin, M.M.
Xuzhou Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,Professor
Study Record Dates
First Submitted
March 9, 2014
First Posted
March 17, 2014
Study Start
June 1, 2010
Primary Completion
February 1, 2014
Study Completion
December 1, 2015
Last Updated
March 17, 2014
Record last verified: 2014-03