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

Primary Purpose

Salivary Gland Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

brachytherapy

IMRT

About this trial

This is an interventional treatment trial for Salivary Gland Cancer focused on measuring inoperable salivary gland cancer, brachytherapy, intensity-modulated radiation therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University, School and Hospital of StomatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

brachytherapy

IMRT

Arm Description

Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

progression-free survival

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.

overall survival

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.

Full Information

NCT ID

NCT02048254

First Posted

January 23, 2014

Last Updated

June 10, 2016

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT02048254

Brief Title

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

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Salivary Gland Cancer

Keywords

inoperable salivary gland cancer, brachytherapy, intensity-modulated radiation therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

brachytherapy

Arm Type

Experimental

Arm Description

Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy

Arm Title

IMRT

Arm Type

Active Comparator

Arm 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.

Intervention Type

Radiation

Intervention Name(s)

brachytherapy

Intervention Type

Radiation

Intervention Name(s)

IMRT

Other Intervention Name(s)

intensity-modulated radiation therapy

Primary Outcome Measure Information:

Title

local control rate

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

progression-free survival

Description

Time Frame

2 years

Title

overall survival

Description

Time Frame

From date of randomization until the date of death from any cause, assessed up to 2 years

Other Pre-specified Outcome Measures:

Title

quality of life

Description

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.

Time Frame

2 year

Title

The incidence of radiation-related adverse reactions

Description

according to NCI-Common Toxicity Criteria Adverse Event （CTCAE）4.0 standard

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shuming Liu, Doctor

Phone

0086-13520162017

kqlsm@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yan Shi, Doctor

shiyan_sy@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianguo Zhang, Doctor

Organizational Affiliation

Peking University, School of Stomatolgy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yan Sun, Doctor

Organizational Affiliation

Peking Univesity, Beijing Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University, School and Hospital of Stomatology

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100081

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuming Liu, Doctor

Phone

13520162017

kqlsm@126.com

First Name & Middle Initial & Last Name & Degree

Jianguo Zhang, Doctor

rszhang@126.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

26951097

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.

Results Reference

derived

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

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