Clinical trial NCT03916367: CT-guided Radioactive I-125 Seeds Implantation for Early Stage Lung Cancer
Official title: Clinical Outcome of CT-guided Radioactive Iodine-125 Seeds Implantation for Inoperable Early Stage Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Stage Non-small Cell Lung Cancer
Keywords: radioactive iodine-125 seeds implantation
non-small cell lung cancer
early stage
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local control time
timeFrame: Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
measure: Overall survival time
timeFrame: Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Radiation Oncology, Peking University Third Hospital
name: Junjie Wang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: