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

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

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.

Study Overview

• Status: Completed
• Conditions: Early Stage Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: CT-guided Radioactive I-125 Seeds Implantation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 39

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018 were included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early Stage Lung Cancer; The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Junjie Wang, M.D. Ph.D., Department of Radiation Oncology, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2010
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; early stage; radioactive iodine-125 seeds implantation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CNRBG-81532-ESNSCLC-RISI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of the study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No