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

NCT04266327 | Unknown

• 1 other identifier: CNRBG-2019-MST-RISI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brachytherapy; Squamous Cell Carcinomas

Keywords

I-125 seed implantation; radiotherapy; Recurrent; Metastatic Squamous cell carcinomas

Outcome Measures

Primary Outcomes (2)

• 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.

  3 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.

  3 years

Secondary Outcomes (2)

• Overall survival time

  3 years

• progression-free survival

  3 years

Study Arms (1)

I-125 Seed Implantation

EXPERIMENTAL

All the enrolled patients were treated with ct-guided radioactive i-125 seed implantation assisted by 3D printing template.Prescription dose 110-130gy.

Radiation: 3D-printing Template-assisted CT-guided I-125 Seed Implantation

Interventions

3D-printing Template-assisted CT-guided I-125 Seed Implantation RADIATION

(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seed 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.

I-125 Seed Implantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) age 18-75 years
• (2) the lesion was located at the thoracic entrance, pathologically diagnosed as lymph node metastatic squamous cell carcinoma, and relapsed after radiotherapy. The diameter of the lesion was ≤5cm
• (3) no systemic metastasis or metastasis, the metastasis has been controlled by early treatment
• (4) no bleeding tendency, anticoagulant treatment and (or) anti-platelet coagulation drugs should be at least 1 week before the seed implantation treatment
• (5) not complicated with serious or uncontrolled basic diseases (such as serious or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, etc.)
• (6) there is a suitable puncture path, is expected to reach the treatment dose;7 KPS\> score of 70, expected to be able to tolerate puncture/particle therapy, the expected survival time is more than 3 months

You may not qualify if:

• (1) extensive invasion of the lesion or surrounding of large blood vessels or large scope of liquefaction necrosis inside the lesion, high risk of expected puncture bleeding or poor particle distribution
• (2) puncture site infection and/or ulcer
• (3) pregnant women, nursing women, children and mental patients
• (4) patients who are participating in other clinical studies
• (5) poor compliance, unable to complete the treatment
• (6) the researchers consider it inappropriate to participate in the clinical trial

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junjie Wang, M.D. Ph.D

  Department of Radiation Oncology, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Ji, M.D.

CONTACT

008618710002823; aschoff@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients meeting the inclusion criteria were enrolled successively in the order of admission and treatment. The dose interval in this study was set as 110-130gy. A total of 30 patients were expected to be enrolled, including 15 patients 110-120gy and 15 patients 120-130gy.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: May 1, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 2 years 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.

Locations

CN (1)