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Iodine

Cadexomer iodine

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.

brachytherapy

IMRT

Shuming Liu, Doctor

Yan Shi, Doctor

Jianguo Zhang, Doctor

Yan Sun, Doctor

* 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.

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 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

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.

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

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer	NCT02048254	Salivary Gland ...	brachytherapy IMRT	18 Years - 80 Years	Peking University
Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer	NCT02048254	Salivary Gland ...	brachytherapy IMRT	18 Years - 80 Years	Peking University

Spots Global Cancer Trial Database for inoperable salivary gland cancer