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

NCT04071418 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-12-27

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

3D-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.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Junjie Wang, M.D. Ph.D. · Department of Radiation Oncology, Peking University Third Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2024-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071418 on ClinicalTrials.gov