Clinical trial · Interventional
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
NCT02048254CI-TRIAL-00022565unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- brachytherapy
- description
- Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy
- interventionNames
- Radiation: brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- IMRT
- description
- 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.
- interventionNames
- Radiation: IMRT
Primary outcomes (1)
- measure
- local control rate
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLiu 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 26951097