CT-guided Radioactive I-125 Seeds Implantation for Early Stage Lung Cancer

Early Stage Non-small Cell Lung Cancer Clinical Trial

Official title:

Clinical Outcome of CT-guided Radioactive Iodine-125 Seeds Implantation for Inoperable Early Stage Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916367
• Other study ID #: CNRBG-81532-ESNSCLC-RISI
• Status: Completed
• Start date: December 15, 2010
• Est. completion date: February 15, 2019

Study information

• Verified date: April 2019
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study observes the efficacy and side effects of CT-guided radioactive iodine-125 seed brachytherapy in inoperable early stage non-small cell lung cancer retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

Description:

Radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. This study collects the data of patients with early stage (stage I-II, N0) non-small cell lung cancer who underwent CT-guided radioactive Iodine-125 seed implantation from 2010 to 2018. The investigators evaluate the dose that covers 90% target volume(D90) and other parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• histological proven non-small cell lung cancer

• UICC (Union for International Cancer Control) stage was T1-3N0M0 (stage Ia-IIb)

• inoperable and CT-guided radioactive iodine-125 seeds brachytherapy was used as the initial treatment without external beam radiotherapy

Exclusion Criteria:

• actual dose of covers 90% target volume (D90) less than 100 Gy in postoperative validation

• case information and/or follow-up information was unavailable

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Early Stage Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• CT-guided Radioactive I-125 Seeds Implantation
The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control time	The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.	Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
Primary	Overall survival time	The time from the date of seeds implantation to the date of death from any cause or the date of last observation.	Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
Secondary	Incidence of adverse events	The adverse events were evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event was measured.	Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.