Malignant Tumor of Head and/or NeckNCT05421507
3D-PCT Combined With CT-guided Radioactive I-125 Seed Implantation in the Treatment of Head and Neck Tumors
An observational study of Malignant Tumor of Head and/or Neck, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumor of Head and/or Neck
- What is being tested?
- Radioactive Iodine-125 Seeds Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 28 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology of Peking university third hospital
Beijing
Bin Qiu, 01082265968, 542122203@qq.com
About this study
Official title: 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
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.
Read the detailed description
Iodine-125 seeds Implantation (RISI) for the treatment of tumors, mainly with the help of imaging guidance, the radioactive I-125 seeds radioactive source is directly implanted into the tumor tissue, and the purpose of killing tumor cells is achieved through the continuous release of radiation by radionuclide. At present, it has been clinically used in the local treatment of tumors in head and neck, chest, abdomen, pelvis, spine, columns and limbs. The main technical difficulties in implementing RISI lies in the complexity of operation and the control of operation quality.In the era of unarmed puncture, the quality of operation is difficult to guarantee, and the therapeutic effect is quite different.In 2015, our unit carried out RISI technology under the guidance of 3D model plates, which significantly improved the treatment accuracy of RISI.
The current 3D printing templates are divided into two types: non-coplanar template (3D-PNCT) and coplanar template (3D-PCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of non-coplanar mold board, a considerable number of patients can be well treated with coplanar template.Compared with the non-coplanar individualized template, the coplanar template has the advantages of accurate needle path control, rapid needle path adjustment, convenient real-time optimization, batch production without waiting for template printing time, and the operation is easy to process, easy for doctors to grasp quickly, the cost is lower than non-coplanar template, and easy to carry out at the grass-roots level. However, most of the existing clinical application data of the template come from the non-coplanar template, and the dosimetry, needle path error and clinical effect of particle implantation guided by the coplanar template are still lack of research. Therefore, this study intends to explore the coplanar template technology and analyze the safety and effectiveness of 3D printing coplanar template combined with CT-guided I-125 seeds implantation in the treatment of head and neck malignant tumors.
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
- Being tested
- Radioactive Iodine-125 Seeds Implantation
- Keywords
- iodine-125 seeds implantation, 3D printing non co-planar template, Malignant Tumor of Head and/or Neck
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Iodine-125 Seeds ImplantationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radioactive Iodine-125 Seeds Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 length of time during and after the treatment of the head and neck tumors, that a patient lives with the disease but it does not get worse.
Measured: 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
Overall survival (OS) is defined as the time from follow up to death.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jun 2022
- Primary completion28 May 2024 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumor of Head and/or NeckStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Bin, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421507
- Sponsor's protocol ID
- CHiECRCT20220018
- Status last verified
- Jul 2022
- First submitted
- 24 May 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05421507
- Acronym / sponsor ID
- CHiECRCT20220018
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 May 2024 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Iodine-125 seeds Implantation (RISI) for the treatment of tumors, mainly with the help of imaging guidance, the radioactive I-125 seeds radioactive source is directly implanted into the tumor tissue, and the purpose of killing tumor cells is achieved through the continuous release of radiation by radionuclide. At present, it has been clinically used in the local treatment of tumors in head and neck, chest, abdomen, pelvis, spine, columns and limbs. The main technical difficulties in implementing RISI lies in the complexity of operation and the control of operation quality.In the era of unarmed puncture, the quality of operation is difficult to guarantee, and the therapeutic effect is quite different.In 2015, our unit carried out RISI technology under the guidance of 3D model plates, which significantly improved the treatment accuracy of RISI.
The current 3D printing templates are divided into two types: non-coplanar template (3D-PNCT) and coplanar template (3D-PCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of non-coplanar mold board, a considerable number of patients can be well treated with coplanar template.Compared with the non-coplanar individualized template, the coplanar template has the advantages of accurate needle path control, rapid needle path adjustment, convenient real-time optimization, batch production without waiting for template printing time, and the operation is easy to process, easy for doctors to grasp quickly, the cost is lower than non-coplanar template, and easy to carry out at the grass-roots level. However, most of the existing clinical application data of the template come from the non-coplanar template, and the dosimetry, needle path error and clinical effect of particle implantation guided by the coplanar template are still lack of research. Therefore, this study intends to explore the coplanar template technology and analyze the safety and effectiveness of 3D printing coplanar template combined with CT-guided I-125 seeds implantation in the treatment of head and neck malignant tumors.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck tumors with local recurrence or metastasis | – | Radiation: Radioactive Iodine-125 Seeds ImplantationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioactive Iodine-125 Seeds ImplantationRadioactive 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. | Radiation | Patients with head and neck tumors with local recurrence or metastasis |
Primary outcome
Adverse events(operation-related complications and radiation side effects)
Time frame: 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.
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).
2 secondary outcomes
Local progression free survival
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Radiation Oncology of Peking university third hospital
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor of Head and/or Neck, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events(operation-related complications and radiation side effects) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.