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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Early Stage Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: CT-guided Radioactive I-125 Seeds Implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Stage Lung Cancer<br>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<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radioactive iodine-125 seeds implantation, non-small cell lung cancer, early stage