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The efficacy of iodine-125 permanent brachytherapy versus intensity-modulated radiation for inoperable salivary gland malignancies: study protocol of a randomised controlled trial.
Liu, SM, Wang, HB, Sun, Y, Shi, Y, Zhang, J, Huang, MW, Zheng, L, Lv, XM, Zheng, BM, Reilly, KH, et al
BMC cancer. 2016;:193
Abstract
BACKGROUND Radiation therapy is the method of choice for subjects with inoperable salivary gland malignancies. I-125 brachytherapy, delivering a high radiation dose to a tumor but sparing surrounding normal tissues, is supposed to be ideal modality for the treatment of salivary gland malignancies. We designed a randomised controlled clinical trial to compare the efficacy of I-125 permanent brachytherapy (PBT) versus intensity-modulated radiation therapy (IMRT) for inoperable salivary gland malignancies. METHODS/DESIGN In this study, inclusion criteria are subjects with inoperable salivary gland malignancies, aged 18-80 years, have provided informed consent, with at least one measurable tumor focus, be able to survive ≥3 months, Karnofsky performance status ≥60, have adequate hematopoietic function of bone marrow, have normal liver and kidney function, and are willing to prevent pregnancy. Exclusion criteria include a history of radiation or chemotherapy, a history of other malignant tumors in the past 5 years, receiving other effective treatments, participating in other clinical trials, with circulatory metastasis, cognitive impairment, severe cardiovascular and cerebrovascular diseases, acute infection, uncontrolled systemic disease, history of interstitial lungdisease, and being pregnant or breast feeding. The study will be conducted as a clinical, prospective, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 90 subjects. Subjects with inoperable salivary gland malignancies are randomised to receive either I-125 PBT or IMRT, with stratification by tumor size and neck lymph node metastasis. Participants in both groups will be followed up at 2, 4, 6, 9, 12, 15, 18, 21 and 24 months after randomization. The primary outcome is local control rate of the primary site (based on imaging findings and clinical examination, RECIST criteria) in 1 year. Secondary outcomes are progression-free survival, overall survival, quality of life (QOL) measured with the European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and QLQ-H&N35) of Chinese version, and safety of treatment. Chi-squared test is used to compare the local control rates in both groups. The survival curves are estimated by the Kaplan-Meier method, and log-rank test is used to test the significant difference. DISCUSSION Only few observational studies have investigated the effect of I-125 PBT on inoperable salivary gland malignancies. To our knowledge, this is the first randomised controlled trial to investigate the efficacy of I-125 PBT for subjects with inoperable salivary gland malignancies, and will add to the knowledge base for the treatment of these subjects. TRIAL REGISTRATION The study is registered to Clinical Trials.gov ( NCT02048254 ) on Jan 29, 2014.
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The incidence of radioepidermitis and the dose-response relationship in parotid gland cancer patients treated with 125I seed brachytherapy: incidence of radioepidermitis and the dose-response relationship.
Mao, MH, Zhang, JG, Zheng, L, Gao, H, Zhang, J, Liu, SM, Huang, MW, Shi, Y
Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]. 2015;(1):26-33
Abstract
BACKGROUND We studied the incidence and dose-response relationship of radioepidermitis in parotid gland carcinoma patients treated with [(125)I] seed brachytherapy in the hopes of designing an optimized pre-implant treatment plan that would reduce the incidence and severity of radioepidermitis in patients receiving this therapy. PATIENTS AND METHODS Between January 2007 and May 2010, 100 parotid gland cancer patients were treated postoperatively with [(125)I] seed brachytherapy. The matched peripheral dose (MPD) was 80-140 Gy, and [(125)I] seed activity was 0.7-0.8 mCi. The mean dose delivered to the skin was calculated in the post-implant CT on day 0 following implantation. Grades of acute and late dermatitis were evaluated at 2, 6, 12, and 18 months post-implantation. RESULTS Most patients experienced grade 0-2 acute and late skin side effects (86 and 97%, respectively), though a small subset developed severe complications. Most grade 1-3 effects resolved within 6 months of implantation, though some grade 1-3 effects and all grade 4 effects remained unchanged throughout the 18-month follow-up period. Grade 3 and 4 effects were most prominent (75 and 25%, respectively) with doses of 110-140 Gy; doses higher than 140 Gy produced only grade 4 effects. CONCLUSION [(125)I] seed brachytherapy produced acceptable levels of acute and late radioepidermitis with a good clinical outcome. A mean dose under 100 Gy delivered to the skin was safe, though doses of 110-140 Gy should be given with caution and extra monitoring; doses greater than 140 Gy are dangerous and likely to produce grade 4-5 effects.
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A digital model individual template and CT-guided 125I seed implants for malignant tumors of the head and neck.
Huang, MW, Liu, SM, Zheng, L, Shi, Y, Zhang, J, Li, YS, Yu, GY, Zhang, JG
Journal of radiation research. 2012;(6):973-7
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Abstract
To enhance the accuracy of radioactive seed implants in the head and neck, a digital model individual template, containing information simultaneously on needle pathway and facial features, was designed to guide implantation with CT imaging. Thirty-one patients with recurrent and local advanced malignant tumors of head and neck after prior surgery and radiotherapy were involved in this study. Before (125)I implants, patients received CT scans based on 0.75mm thickness. And the brachytherapy treatment planning system (BTPS) software was used to make the implantation plan based on the CT images. Mimics software and Geomagic software were used to read the data containing CT images and implantation plan, and to design the individual template. Then the individual template containing the information of needle pathway and face features simultaneously was made through rapid prototyping (RP) technique. All patients received (125)I seeds interstitial implantation under the guide of the individual template and CT. The individual templates were positioned easily and accurately, and were stable. After implants, treatment quality evaluation was made by CT and TPS. The seeds and dosages distribution (D(90),V(100),V(150)) were well meet the treatment requirement. Clinical practice confirms that this approach can facilitate easier and more accurate implantation.
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[Radioactive seed implantation for the treatment of mediastinal malignant tumors and lymph node metastases in 43 cases].
Luo, L, Wang, H, Ma, H, Cai, C, Zhang, J, Zou, H
Zhongguo fei ai za zhi = Chinese journal of lung cancer. 2011;(12):933-7
Abstract
BACKGROUND AND OBJECTIVE The locations of mediastinal malignant tumor lesions are deep and occult, and are close to the pericardium, trachea, or major vessels. Therefore, the possibility of surgical resection is slim, and cryoablation and thermal ablation are restricted. In current study, image and life quality data were compared before and after 125I seeding therapy to investigate its safety and clinical effects. METHODS From July 2010 to July 2011, a 43-patient follow-up of pathologically confirmed cancers, including 21 cases of primary mediastinal squamous lung cancer, 9 cases of primary esophagus cancer, and 13 cases of lymph node metastases were completed. Among these, 18 cases presented with tracheal stenosis >50%, 9 cases had esophageal obstruction, and 9 cases had superior vena cava reflux disorder. Each lesion was implanted with 10 to 60 pieces of 125I particles, with an average of 30.79±14.23. CT data at 2, 4, 6, and 12 months after therapy were obtained to evaluate the local lesion outcome. The quality of life of the patients as well as survival data was also recorded. RESULTS The overall success rate of the operation was 100%. The longest time of follow-up was 12 months. At 6 months, 37 patients were alive, and the half-year survival rate was 85.0%. In terms of local lesions, 30 cases of PR and 7 cases of NC were found. The clinical effective rate was 81.08%, and the clinical beneficial rate was 100%. At 12 months after therapy, 31 patients were alive, and the one-year survival rate was 60.5%. In terms of local lesions, 16 cases of CR, 7 cases of PR, 2 cases of NC, and 6 cases of PD were found. The clinical effective rate was 74.19%, and the clinical beneficial rate was 80.65%. The KPS score increased after the treatment (P=0.000). Three cases of pneumothorax presented after treatment, and no severe complications, such as vessel, trachea, recurrent laryngeal nerve, or pericardiocentesis injuries, were found. CONCLUSIONS Radiation seed implantation in mediastinal malignant tumors is a relatively safe technique with high success rate, considerable efficacy, and clear clinical value in advanced cancer treatment.