Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer
A Randomized Control Trial (RCT) of Using Iodine-125 Brachytherapy Versus Intensity-modulated Radiation Therapy (IMRT) to Treat Inoperable Salivary Gland Cancer
1 other identifier
interventional
90
1 country
1
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2014
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 13, 2016
June 1, 2016
3.8 years
January 23, 2014
June 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
progression-free survival
2 years
overall survival
From date of randomization until the date of death from any cause, assessed up to 2 years
Other Outcomes (2)
quality of life
2 year
The incidence of radiation-related adverse reactions
2 years
Study Arms (2)
brachytherapy
EXPERIMENTALIodine-125 radioactive seeds permanent interstitial implantation brachytherapy
IMRT
ACTIVE COMPARATORIMRT (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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients are diagnosed histologically as primary or recurrent salivary gland cancers that may occur in either major salivary glands or minor salivary glands.
- 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.
You may not qualify if:
- Radioactive therapy history of head and neck.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University, School and Hospital of Stomatology
Beijing, Beijing Municipality, 100081, China
Related Publications (1)
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.
PMID: 26951097DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jianguo Zhang, Doctor
Peking University, School of Stomatolgy
- PRINCIPAL INVESTIGATOR
Yan Sun, Doctor
Peking Univesity, Beijing Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 23, 2014
First Posted
January 29, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
June 13, 2016
Record last verified: 2016-06