RecruitingNCT04071418

I-125 Seeds Implantation in the Treatment of Recurrent Lung Cancer After Radiotherapy

Safety and Efficacy of 3D-printing Template Assisted CT-guided Radioactive I-125 Seeds Implantation in the Treatment of Recurrent Lung Cancer After External Beam Radiotherapy: a Multicenter, Prospective Cohort Study


Sponsor

Peking University Third Hospital

Enrollment

30 participants

Start Date

May 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Patients with recurrence after radiotherapy are often encountered in clinical practice.Patients with recurrence after radiotherapy are less likely to undergo surgery or secondary radiotherapy, and the guidelines recommend only systemic therapy, although the effective rate is relatively low.For patients with local recurrence without distant metastasis, local treatment is still significant.Radioactive I-125 Seed Implantation (RISI) treatment is to I-125 Radioactive nuclide directly inside the implanted tumors, make its rays to continuous destruction of tumor cells, have inside the tumor target high dose, low dose of normal tissue around, and its radiation is low dose rate, in theory, more conducive to the protection of the normal tissue, more suitable for salvage treatment of recurrence after radiotherapy lesions.Some retrospective studies on RISI treatment of NSCLC showed that the local control rate was up to 25%-80%, and there were few reports of toxic and side effects, suggesting that it had good efficiency and safety.Therefore, for patients with recurrent NSCLC after chest radiotherapy, RISI may be considered.And template technology, 3 d printing is a new kind of technology in recent years, can be individualized and human body surface, the guide posts on the the direction of the puncture needle can be accurately controlled, the current data show that in the template with CT guided by solid tumors as well had significantly higher accuracy, as the actual target dose of basic postoperative can reach the design request of the preoperative planning, so the application of 3D printing template helps to further improve the operation efficiency and safety, also has potential promotion effect to curative effect.The purpose of this study was: (1) to observe the efficacy, toxic and side effects of RISI in the treatment of recurrent NSCLC after radiotherapy under the guidance of 3D printing template assisted CT, and to evaluate its safety and effectiveness;(2) to explore the relationship between the efficacy, toxicity and side effects of RISI dose in the treatment of recurrent NSCLC after radiotherapy;(3) analyze the relevant influencing factors affecting the effect/toxicity of RISI in the treatment of recurrent NSCLC after radiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called radioactive seed implantation (using iodine-125 seeds) as a treatment for non-small cell lung cancer (NSCLC) that has come back in the same area after previous radiation therapy. The seeds are tiny radioactive particles implanted directly into the tumor to deliver targeted radiation. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with non-small cell lung cancer (NSCLC) that has come back after prior radiation treatment - The recurring tumor is less than 5 cm in size - Any other areas of cancer spread have been controlled by prior treatment - You are in good general health (KPS score above 70) - You do not have significant bleeding tendencies or major uncontrolled health conditions **You may NOT be eligible if...** - Your lung function is severely compromised (severe emphysema, interstitial lung disease) - The tumor has large areas of internal breakdown (necrosis) making seed placement unsafe - You have serious uncontrolled conditions like high blood pressure, diabetes, or organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION3D-printing Template-assisted CT-guided I-125 Seeds Implantation

(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seeds implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume; Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc. Regular follow-up was conducted after treatment.


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT04071418


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