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The target population are those patients with inoperable salivary gland derived primary or recurrent cancer, including local advanced primary salivary gland cancer which could not be resected completely; recurrent salivary gland cancer which could not be resected completely; T3/T4 tumor which could not tolerate surgery due to severe combined disease. The subjects would be divided into Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy and intensity-modulated radiation therapy randomly. During the follow-up period, the efficacy and the safety index would be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brachytherapy | Experimental | Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy |
|
| IMRT | Active Comparator | IMRT (intensity-modulated radiation therapy), 6 Millivolt (MV)-x fractionated irradiation, 1 time/day, 5 times a week, till the end. Add up to 33 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation |
| ||
| IMRT |
| Measure | Description | Time Frame |
|---|---|---|
| local control rate | According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | progression-free survival is definite as the time of death of tumor progression event emerges from the patient was randomize. According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded. No respondent means the tumor advances at the first day. |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale Quality of life Questionnaire (QLQ)-C30 (V3.0) and the QLQ-H & N35 (V1.0) of quality of life questionnaire. | 2 year |
| The incidence of radiation-related adverse reactions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuming Liu, Doctor | Contact | 0086-13520162017 | kqlsm@126.com | |
| Yan Shi, Doctor | Contact | shiyan_sy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianguo Zhang, Doctor | Peking University, School of Stomatolgy | Study Director |
| Yan Sun, Doctor | Peking Univesity, Beijing Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University, School and Hospital of Stomatology | Recruiting | Beijing | Beijing Municipality | 100081 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26951097 | Derived | Liu SM, Wang HB, Sun Y, Shi Y, Zhang J, Huang MW, Zheng L, Lv XM, Zheng BM, Reilly KH, Yan XY, Ji P, Wu YF, Zhang JG. The efficacy of iodine-125 permanent brachytherapy versus intensity-modulated radiation for inoperable salivary gland malignancies: study protocol of a randomised controlled trial. BMC Cancer. 2016 Mar 7;16:193. doi: 10.1186/s12885-016-2248-7. |
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| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
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|
|
| 2 years |
| overall survival | Refers to the result from a random start time to death of any cause. Records from the beginning of the random time to time of any cause of death. Shedding of subjects censored cases recorded censored time. | From date of randomization until the date of death from any cause, assessed up to 2 years |
according to NCI-Common Toxicity Criteria Adverse Event (CTCAE)4.0 standard |
| 2 years |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |