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

NCT03916367 | Completed

• 1 other identifier: CNRBG-81532-ESNSCLC-RISI
• Study Type: observational
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Early Stage Non-small Cell Lung Cancer

Keywords

radioactive iodine-125 seeds implantation; non-small cell lung cancer; early stage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of adverse events

  Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.

Study Arms (1)

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

Interventions

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.

Early Stage Lung Cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• actual dose of covers 90% target volume (D90) less than 100 Gy in postoperative validation
• case information and/or follow-up information was unavailable

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Junjie Wang, M.D. Ph.D.

  Department of Radiation Oncology, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: December 15, 2010
• Primary Completion: December 15, 2018
• Study Completion: February 15, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.