Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer
NCT ID: NCT02048254
Last Updated: 2016-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
90 participants
INTERVENTIONAL
2014-02-28
2018-06-30
Brief Summary
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* To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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brachytherapy
Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy
brachytherapy
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.
IMRT
Interventions
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brachytherapy
IMRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The inoperable circumstance include: Primary or recurrent salivary gland cancers that could not be resected completely or could not get negative incision.
* T3/T4 tumor patients with severe medical comorbidities could not accept the high risk of perioperative complications.
* At least one measurable tumor or focus (according to RESIST 1.1 Standard).
* Karnofsky score\> 60.
* Survival time predicted ≥ 3months;
* HGB≥9 g/dL, WBC≥3.0×10\^9/L, NEUT≥1.5×10\^9/L, platelet count (PLT)≥ 100×10\^9/L; TBIL≤1.5 upper limit of normal, Alanine aminotransferase (ALT)/AST≤3 upper limit of normal; Cera≤1.5 upper limit of normal.
* Male or female with fertility in the experiment are willing to take contraceptive measures.
Exclusion Criteria
* Suffering from other malignant tumor in recent five years, except skin basal cell carcinoma or carcinoma in situs of cervix.
* Chemotherapy history.
* Receiving other effective therapy.
* Distant metastases.
* Pathologic result as squamous cell carcinoma.
* Neurological or mental abnormalities which affect cognitive ability.
* Severe cardiovascular and cerebrovascular diseases, such as heart failure (NYHA III-IV class), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmias, uncontrolled hypertension, myocardial infarction or cerebral infarction within past six months.
* Active serious clinical infections :\> Class 2 NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0 within 14 days before randomization, including active tuberculosis.
* HIV infection or active hepatitis B or hepatitis C.
* Uncontrolled systemic diseases, such as poorly controlled diabetes mellitus.
* Medical history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or baseline chest X-ray / CT showed evidence of interstitial lung disease;
* Pregnancy (via urine β-human chorionic gonadotropin test to determine) or breastfeeding.
18 Years
80 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Jianguo Zhang
Professor
Principal Investigators
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Jianguo Zhang, Doctor
Role: STUDY_DIRECTOR
Peking University, School of Stomatolgy
Yan Sun, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking Univesity, Beijing Cancer Hospital
Locations
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Peking University, School and Hospital of Stomatology
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PUCRP201308
Identifier Type: -
Identifier Source: org_study_id
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