3D-PCT Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of Head and Neck Tumors

NCT05421507 | Recruiting

• 1 other identifier: CHiECRCT20220018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to verify the accuracy, short-term efficacy and side effects of 3D printing coplanar template combined with CT-guided I-125 seeds implantation in the treatment of malignant tumors of the head and neck.

Conditions

Malignant Tumor of Head and/or Neck

Keywords

iodine-125 seeds implantation; 3D printing non co-planar template; Malignant Tumor of Head and/or Neck

Outcome Measures

Primary Outcomes (1)

• Adverse events(operation-related complications and radiation side effects)

  Adverse events are commonly used in the term v5.0 to evaluate the side effects after treatment. The evaluation organ depends on the specific condition of the treatment site and the tissue adjacent to the target area. Other adverse events included particle displacement, needle implantation transfer, and operation-related complications (bleeding, nerve injury, etc).

  The side effects were completely observed after 2 years of follow-up.The follow-up interval was calculated from the completion of the treatment, once every 3 months in the first year and once every 6 months in the second year.

Secondary Outcomes (2)

• Local progression free survival

  The local progression free survival were completely observed after 2 years of follow-up.The follow-up interval was calculated from the completion of the treatment, once every 3 months in the first year and once every 6 months in the second year.

• Overall survival

  he overall survival were completely observed after 2 years of follow-up.The follow-up interval was calculated from the completion of the treatment, once every 3 months in the first year and once every 6 months in the second year.

Study Arms (1)

Patients with head and neck tumors with local recurrence or metastasis

The patients in the group were treated with routine clinical treatment: 3D-PCT combined with CT-guided I-125 seeds implantation in the treatment of head and neck malignant tumors. The prescription dose is given 110-150Gy according to tumor pathological type, tumor volume, history of previous radiotherapy and different surrounding normal tissues according to experience and routine diagnosis and treatment.

Radiation: Radioactive Iodine-125 Seeds Implantation

Interventions

Radioactive Iodine-125 Seeds Implantation RADIATION

Radioactive Iodine-125 Seeds Implantation(RISI) belongs to permanent inter-tissue brachytherapy. Guided by CT or ultrasound,radioactive I-125 seeds are implanted into tumor tissue, and radioactive I-125 continuously releases radiation to kill tumor cells.Radioactive I-125 seeds can reach a higher dose in the tumor, and the dose of the normal tissue around the tumor is lower, and the damage to the normal tissue is less while reaching the radical dose. The NCCN guidelines recommend RISI as the standard treatment for early prostate cancer. For early prostate cancer, RISI can achieve comparable efficacy as surgery, complications and side effects are lower than surgery, therefore patients can obtain better quality of life. RISI is also recommended by NCCN as one of the treatments for locally recurrent rectal cancer. Several studies have confirmed that RISI is safe and effective in the treatment of locally advanced or recurrent head and neck, chest, abdominal and retroperitoneal tumors.

Patients with head and neck tumors with local recurrence or metastasis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample size was calculated by One-Sample Log-rank Tests in PASS 15 software. Class I error probability (α) = 0. 05; class II error probability (β) = 0. 2, that is, power = 1-β = 0. 8. According to the experience and data of the center, it is assumed that the local control index can be more than doubled by reducing RISI, that is, Hazard Rates113 (M1:M0) = 2:1. Finally the sample size was calculated to be 25 cases, and the sample size of was estimated to be 30 cases considering the 20% loss of follow-up rate.

You may qualify if:

• the age is 18-80 years old;
• the pathological diagnosis is clear, patients with local recurrence / metastasis of head and neck tumor after operation or external radiotherapy;
• the tumor diameter ≤ 5cm, the number of lesions ≤ 3;
• there is a suitable puncture path, and the target dose of pre can reach the prescribed dose;
• KPS ≥ 70 points, the expected survival time is more than 3 months;
• patients have signed a consent form for I-125 seeds implantation therapy;
• patients have signed the consent form of knowing emotions to participate in this observational study;

You may not qualify if:

• coagulation dysfunction;
• tumor surface rupture, or tumor memory liquefied and necrotic in a large range, with poor expected particle distribution;
• severe underlying diseases, resulting in unsafe completion of I-125 seeds implantation therapy, including active infections requiring drug treatment;
• mental abnormalities affecting cognitive ability;
• poor compliance and inability to complete treatment;
• those who were considered unsuitable to participate in this clinical trial;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Radiation Oncology of Peking university third hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principe Investigator

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 16, 2022
• Study Start: June 1, 2022
• Primary Completion: May 28, 2024
• Study Completion (Estimated): May 28, 2026
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)