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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916367
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Early Stage Non-small Cell Lung Cancer 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.

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcome of CT-guided Radioactive Iodine-125 Seeds Implantation for Inoperable Early Stage Non-small Cell Lung Cancer
Actual Study Start Date : December 15, 2010
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916367


Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Junjie Wang, M.D. Ph.D. Department of Radiation Oncology, Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03916367    
Other Study ID Numbers: CNRBG-81532-ESNSCLC-RISI
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months of the study completion.
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
radioactive iodine-125 seeds implantation
non-small cell lung cancer
early stage
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms