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Trial record 1 of 1 for:    NCT02048254
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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
Sponsor:
Information provided by (Responsible Party):
Jianguo Zhang, Peking University

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.

Condition or disease Intervention/treatment Phase
Salivary Gland Cancer Radiation: brachytherapy Radiation: IMRT Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: brachytherapy
Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy
Radiation: 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.
Radiation: IMRT
Other Name: intensity-modulated radiation therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. The incidence of radiation-related adverse reactions [ Time Frame: 2 years ]
    according to NCI-Common Toxicity Criteria Adverse Event (CTCAE)4.0 standard



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shuming Liu, Doctor 0086-13520162017 kqlsm@126.com
Contact: Yan Shi, Doctor shiyan_sy@163.com

Locations
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China, Beijing
Peking University, School and Hospital of Stomatology Recruiting
Beijing, Beijing, China, 100081
Contact: Shuming Liu, Doctor    13520162017    kqlsm@126.com   
Contact: Jianguo Zhang, Doctor       rszhang@126.com   
Sponsors and Collaborators
Peking University
Investigators
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Study Director: Jianguo Zhang, Doctor Peking University, School of Stomatolgy
Principal Investigator: Yan Sun, Doctor Peking Univesity, Beijing Cancer Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jianguo Zhang, Professor, Peking University
ClinicalTrials.gov Identifier: NCT02048254     History of Changes
Other Study ID Numbers: PUCRP201308
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Jianguo Zhang, Peking University:
inoperable salivary gland cancer
brachytherapy
intensity-modulated radiation therapy

Additional relevant MeSH terms:
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Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases