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

Salivary Gland Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02048254
• Other study ID #: PUCRP201308
• Status: Recruiting
• Phase: Phase 3
• First received: January 23, 2014
• Last updated: June 10, 2016
• Start date: February 2014
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Peking University
• Contact: Shuming Liu, Doctor
• Phone: 0086-13520162017
• Email: kqlsm[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß-human chorionic gonadotropin test to determine) or breastfeeding.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Salivary Gland Cancer
• Salivary Gland Neoplasms

Intervention

Radiation:
• brachytherapy

• IMRT

Locations

Country	Name	City	State
China	Peking University, School and Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	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	Yes
Other	The incidence of radiation-related adverse reactions	according to NCI-Common Toxicity Criteria Adverse Event (CTCAE)4.0 standard	2 years	Yes
Primary	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.	1 year	Yes
Secondary	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.	2 years	No
Secondary	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.	From date of randomization until the date of death from any cause, assessed up to 2 years	No