Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer

June 10, 2016 updated by: Jianguo Zhang, Peking University

A Randomized Control Trial (RCT) of Using Iodine-125 Brachytherapy Versus Intensity-modulated Radiation Therapy (IMRT) to Treat Inoperable Salivary Gland Cancer

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shuming Liu, Doctor
  • Phone Number: 0086-13520162017
  • Email: kqlsm@126.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Recruiting
        • Peking University, School and Hospital of Stomatology
        • Contact:
          • Shuming Liu, Doctor
          • Phone Number: 13520162017
          • Email: kqlsm@126.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • intensity-modulated radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
From date of randomization until the date of death from any cause, assessed up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year
The incidence of radiation-related adverse reactions
Time Frame: 2 years
according to NCI-Common Toxicity Criteria Adverse Event （CTCAE）4.0 standard
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Study Director: Jianguo Zhang, Doctor, Peking University, School of Stomatolgy
  • Principal Investigator: Yan Sun, Doctor, Peking Univesity, Beijing Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (ESTIMATE)

January 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUCRP201308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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