Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal Carcinoma
关键词
抽象
描述
Study Design Patients with previously untreated Stages III~IVA (AJCC 6th Edition) of locally advanced NPC, Karnofsky performance status≥70, and good bone marrow, liver and kidney functions (white blood count ≥ 4.0×109/L, platelets ≥ 100×109/L, albumin ≥30 g/L , creatinine ≤100μmol/L) were enrolled on this study. Patients younger than 18, those with a prior (within 5 years) or synchronous malignancy were excluded. Pretreatment evaluations consisted of a history and physical, dental and laboratory studies. The clinical stage was determined based on all information provided by examinations including contrast enhanced CT and magnetic resonance imaging (MRI) of head and neck, Chest X-ray, liver sonography, bone scan, and 18F-FDG-PET. All tumors were histologically confirmed except those of distant sites.
Patients who met the eligibility criteria were randomized 1:1:1 into the three treatment arms: conventional chemoradiotherapy (group A), FDG PET/CT -guided dose escalation chemoradiotherapy (group B) and FMISO PET/CT -guided dose escalation chemoradiotherapy (group C). 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.
Follow-up and statistical analysis Planned patient assessment included physical examination and fiberoptic nasopharyngoscopy every 3 months to 3 years starting at 4 weeks post-treatment. A contrast-enhanced CT or MRI of the head and neck is also obtained at each follow up. After 3 years, the patients were followed yearly thereafter. Suspected recurrences were histologically proven. To assess for distant metastasis, CT of the chest and bone scan were obtained every half a year. During every follow-up visit, treatment toxicity were assessed. Radiotherapy-related toxicities were graded according to the Acute and the Late Radiation Morbidity Scoring Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Chemotherapy-related toxicities (except nausea or alopecia) were graded by the criteria of the WHO.
All events were measured from the date of randomization. OS was defined as the time from the date of radiotherapy to death or the latest date known to be alive. Durations were calculated from the end of treatment. The Kaplan-Meier method was used to calculate the actuarial rates of local control, DFS and OS. The χ2 test was used for comparing incidence rates and categorical variables and Student's t-test was used for comparing the means of continuous variables.
日期
最后验证: | 02/28/2014 |
首次提交: | 03/08/2014 |
提交的预估入学人数: | 03/12/2014 |
首次发布: | 03/16/2014 |
上次提交的更新: | 03/12/2014 |
最近更新发布: | 03/16/2014 |
实际学习开始日期: | 05/31/2010 |
预计主要完成日期: | 01/31/2014 |
预计完成日期: | 11/30/2015 |
状况或疾病
干预/治疗
Radiation: FMISO-PET/CT
Radiation: FDG-PET/CT
Radiation: contrast-enhanced CT
相
手臂组
臂 | 干预/治疗 |
---|---|
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. | 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. |
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. | 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. |
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. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 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, Exclusion Criteria: - 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. |
结果
主要结果指标
1. local progression-free (LPF) survival rates [5 years]
次要成果指标
1. disease-free survival (DFS) [5 years]
2. overall survival (OS) [5 years]
其他成果措施
1. acute toxicities [from treatment start to 4 weeks post-treatment]
2. Late toxicities [from 4 weeks post-treatment to 5 years.]