RISI in the Treatment of Recurrent Metastatic SCC of Thoracic Inlet Lymph

Status Recruiting

Clinical Trial Summary

The malignant tumor at the thoracic entrance is difficult to be surgically removed, and radiotherapy or radiotherapy based comprehensive treatment is often chosen at the initial diagnosis. However, for patients with recurrence after radiotherapy, there is basically no ideal local treatment.The Radioactive i-125 Seed Implantation (RISI) therapy is characterized by high dose within the tumor target area and low dose to surrounding normal tissues, and its radiation dose rate is low, which theoretically benefits the protection of normal tissues and is more suitable for the salvage treatment of recurrent lesions after radiotherapy.3 d printing template technology is through the advance of the preoperative plan design and optimization, to achieve better avoid endanger organs, template of individualized and human body surface after laminating, registration accuracy, its guide pillar to precise control the direction of the needle, the present 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 3 d printing template helps to further improve the operation efficiency and safety, also has potential promotion effect to curative effect. The purpose of this study is: (1) Observe the efficacy, toxicity and side effects of 3d-printed template assisted ct-guided RISI in the treatment of recurrent metastatic squamous cell carcinoma of thoracic inlet lymph node after radiotherapy, and evaluate its safety and effectiveness; (2) to explore the relationship between the efficacy, toxicity and side effects of relapsed metastatic squamous cell carcinoma of thoracic inlet lymph node after radiotherapy with different RISI doses;(3)the related influencing factors affecting the effect/toxicity of RISI in the treatment of relapsed lymph node metastatic squamous cell carcinoma at the thoracic inlet after radiotherapy were analyzed.

Clinical Trial Description

This is a non-randomized, prospective, single-arm, cohort study.Patients meeting the inclusion criteria were enrolled successively in the order of admission and treatment.In this study, the dose interval was set as 110-130gy, and a total of 30 patients were expected to be enrolled. The prescription dose was planned to be grouped into 15 patients of 110-120gy and 120-130gy respectively. The specific situation was subject to the actual postoperative verification dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04266327
Study type	Interventional
Source	Peking University Third Hospital
Contact	Zhe Ji, M.D.
Phone	008618710002823
Email	aschoff@163.com
Status	Recruiting
Phase	N/A
Start date	May 1, 2020
Completion date	April 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

RISI in the Treatment of Recurrent Metastatic SCC of Thoracic Inlet Lymph Nodes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms