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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer; Brachytherapy
• Intervention / Treatment: Radiation: 3D-printing Template-assisted CT-guided I-125 Seeds Implantation

Detailed Description

The purpose of this study was to observe the efficacy and adverse reactions of RISI in the treatment of recurrent NSCLC after radiotherapy, and to evaluate its safety and efficacy.To explore the relationship between the efficacy, toxicity and side effects of recurrent NSCLC treated with different RISI doses after radiotherapy.To analyze the relevant influencing factors affecting the efficacy/toxicity of RISI in the treatment of recurrent NSCLC after radiotherapy.

This study is a non-randomized, prospective, single-arm, cohort study.Patients meeting the inclusion criteria were enrolled consecutively in the order of admission and treatment, and a total of 30 patients were expected to be enrolled.The therapeutic dose range of I-125 was 140-160Gy, and the prescribed dose was intended to be divided into 15 cases of 140-150Gy and 150-160Gy, respectively. The specific situation was subject to the actual postoperative verified dose.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Zhe Ji, M.D.; Phone Number: 008618710002823; Email: aschoff@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Zhe Ji, M.D.; Phone Number: +8618710002823; Email: aschoff@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with reccurent NSCLC after external beam radiotherapy who meet the criteria can be enrolled in the study.

Description

Inclusion Criteria:

• (1) Age 18-75 years old
• (2) Pathological diagnosis of NSCLC, recurrence after radiotherapy, lesion diameter less than 5 cm
• (3) No systemic metastasis or metastasis, metastasis has been controlled by pre-treatment
• (4) No bleeding tendency, anticoagulant therapy and/or anti-platelet coagulant drugs should be stopped for at least one week before seed implantation
• (5) No serious or uncontrolled underlying diseases (such as severe or uncontrolled high). Blood pressure, diabetes mellitus, cardiovascular and cerebrovascular diseases and organ dysfunction, etc.
• (6) There is a suitable puncture path, which is expected to achieve the therapeutic dose
• (7) KPS > 70 points, which is expected to be able to tolerate puncture/RISI therapy, and the expected survival time is longer than 3 months.

Exclusion Criteria:

• (1) Poor basic pulmonary function with severe emphysema, bullae and interstitial pneumonia
• (2) Liquefaction and necrosis in a large area near the mediastinum or focus, with high risk of puncture bleeding or poor seeds distribution
• (3) Infection and ulcer in puncture site
• (4) Pregnant women, lactating women, children and psychiatric patients
• (5) Patients who are participating in other clinical studies
• (6) Poor compliance, unable to complete the treatment
• (7) The researchers think that it is not appropriate to participate in this clinical trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

I-125 Seeds Implantation; All the enrolled patients were treated with CT-guided radioactive I-125 seeds implantation assisted by 3D printing template. Prescription dose 140-160gy.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor control rate	The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.	Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 years.
Incidence of adverse events	The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.	Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 will be followed up every 2-3 months after enrollment. The total follow-up time is 2 years
Progression-free survival	The time between the beginning of treatment and the date of progression of the disease or the date of death for any reasons or the date of last observation.	Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Junjie Wang, M.D. Ph.D., Department of Radiation Oncology, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: radiotherapy; recurrent lung cancer; I-125 seeds implantation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CNRBG-2019-RLC-RISI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 2 years of the study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No