Clinical trial NCT02048254: Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Salivary Gland Cancer
Keywords: inoperable salivary gland cancer
brachytherapy
intensity-modulated radiation therapy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: local control rate
timeFrame: 1 year
Secondary outcomes:
measure: progression-free survival
timeFrame: 2 years
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 2 years
Other outcomes:
measure: quality of life
timeFrame: 2 year
measure: The incidence of radiation-related adverse reactions
timeFrame: 2 years
Locations:
city: Beijing
country: China
facility: Peking University, School and Hospital of Stomatology
state: Beijing
Study officials:
affiliation: Peking University, School of Stomatolgy
name: Jianguo Zhang, Doctor
role: STUDY_DIRECTOR
affiliation: Peking Univesity, Beijing Cancer Hospital
name: Yan Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.