RECRUITINGOBSERVATIONAL

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

A Serial Case, Single-arm, Real-world Study of the Safety and Efficacy of 3D-printed Coplanar Template Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of Head and Neck Tumors

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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; Who Should NOT Join This Trial: - 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; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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; Exclusion Criteria: * 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;

Treatments Being Tested

RADIATION

Radioactive Iodine-125 Seeds Implantation

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.

Locations (1)

Department of Radiation Oncology of Peking university third hospital

Beijing, China