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

Completed

• Conditions: Early Stage Non-small Cell Lung Cancer
• Interventions: Radiation: CT-guided Radioactive I-125 Seeds Implantation

• Registration Number: NCT03916367
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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 Timeline

• Study Start: 2010-12-15
• Primary Completion: 2018-12-15
• Study Completion: 2019-02-15
• Status Verified: 2019-04
• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early Stage Lung Cancer	CT-guided Radioactive I-125 Seeds Implantation	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.

Primary Outcome Measures

Name	Time	Method
Local control time	Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.	The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.
Overall survival time	Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.	The time from the date of seeds implantation to the date of death from any cause or the date of last observation.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.	The adverse events were evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event was measured.