CT-guided Radioactive I-125 Seeds Implantation for Early Stage 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.

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Key information

Conditions

Early Stage Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-guided Radioactive I-125 Seeds Implantation

Radiation

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.

Primary outcomes

Local control time

Time frame: 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

Time frame: 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 outcomes

Incidence of adverse events

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2018
Study completion: 2019
First posted: Apr 16, 2019
Registry last updated: May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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