Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer
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|ClinicalTrials.gov Identifier: NCT02048254|
Recruitment Status : Unknown
Verified June 2016 by Jianguo Zhang, Peking University.
Recruitment status was: Recruiting
First Posted : January 29, 2014
Last Update Posted : June 13, 2016
- To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
- To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
|Condition or disease||Intervention/treatment||Phase|
|Salivary Gland Cancer||Radiation: brachytherapy Radiation: IMRT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Control Trial (RCT) of Using Iodine-125 Brachytherapy Versus Intensity-modulated Radiation Therapy (IMRT) to Treat Inoperable Salivary Gland Cancer|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy
Active Comparator: IMRT
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.
Other Name: intensity-modulated radiation therapy
- local control rate [ Time Frame: 1 year ]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.
- progression-free survival [ Time Frame: 2 years ]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.
- overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 2 years ]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.
- quality of life [ Time Frame: 2 year ]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.
- The incidence of radiation-related adverse reactions [ Time Frame: 2 years ]according to NCI-Common Toxicity Criteria Adverse Event （CTCAE）4.0 standard
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048254
|Contact: Shuming Liu, Doctoremail@example.com|
|Contact: Yan Shi, Doctorfirstname.lastname@example.org|
|Peking University, School and Hospital of Stomatology||Recruiting|
|Beijing, Beijing, China, 100081|
|Contact: Shuming Liu, Doctor 13520162017 email@example.com|
|Contact: Jianguo Zhang, Doctor firstname.lastname@example.org|
|Study Director:||Jianguo Zhang, Doctor||Peking University, School of Stomatolgy|
|Principal Investigator:||Yan Sun, Doctor||Peking Univesity, Beijing Cancer Hospital|