Pancreatic CancerNCT03882866
Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer
A study testing 3D-printed non-coplanar template and 3D-printed coplanar template in people with Pancreatic Cancer, run by Ruijin Hospital at 8 sites in China.
Trial summary
This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 3D-printed non-coplanar template and 3D-printed coplanar template
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 8 sitesChina
- Study dates
- 28 Mar 2019to 30 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Age: 18-80 years
- Cytologically or histologically confirmed pancreatic adenocarcinoma
- Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)
- Single tumor size≤ 6 cm
- Karnofsky performance score （KPS）≥60
- Estimated survival ≥3 months
Show all 15Show fewer
- Without other several comorbidity
- Participants must have adequate organ function:
- WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L
- Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal
- Albumin≥3g/dL
- Total bilirubin ≤3mg/dL
- PT≤3 × institutional upper limit of normal or INR≤2.3
- Creatinine ≤1.5 × institutional upper limit of normal
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with other malignant tumors
- History of other anti-cancer therapy, including surgery,radiation, ablation and so on
- Pregnant or lactating women
- Patients with Immunodeficiency disease
- Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia
- Uncontrolled hypertension
Show all 12Show fewer
- Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)
- Active tuberculosis
- Chronic renal insufficiency
- Other organ failure
- History of organ transplantation
- History of severe mental illness
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Yueyong Xiao, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Fujun Zhang, MD
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
Weifu Lv
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong
Yuliang Li, MD
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu
Jinhe Guo, MD
- Recruiting
Huadong Hospital
Shanghai, Shanghai Municipality
Hong Zhao
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Juan Wang, MD
- Recruiting
Teng Zhou Central People's Hospital
Zaozhuang, Shandong
Kaixian Zhang, MD
About this study
Official title: 3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study
This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.
Read the detailed description
Dosimetric verification was performed after implantation. Pre- and postoperative D90, V100, and V150 were calculated. The success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (ORR)，overall survival (OS)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.
- Conditions
- Pancreatic Cancer
- Being tested
- 3D-printed non-coplanar template, 3D-printed coplanar template
- Keywords
- Iodine-125, Three-Dimensional Printing, Brachytherapy, template
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed non-coplanar templateProcedure or surgery
3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
3D-printed coplanar templateProcedure or surgery
3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed non-coplanar template | Experimental | 3D-printed non-coplanar template is used in this group. Receives: Procedure: 3D-printed non-coplanar template |
| 3D-printed coplanar template | Active comparator | 3D-printed coplanar template is used in this group. Receives: Procedure: 3D-printed coplanar template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
Measured: 24 months
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Measured: 24 months
Incidence of treatment-emergent toxicities of two treatment regimens in patients
The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation.
Measured: 24 months
Quality of life of two treatment regimens in patients
Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start28 Mar 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei General Hospital, Zhongda Hospital, Anhui Provincial Hospital, The Second Hospital of Shandong University, Sun Yat-sen University, Chinese PLA General Hospital, Huadong Hospital, Tengzhou Central People's Hospital
- Responsible party
- Principal investigator, Zhongmin Wang, Ruijin Hospital
- Investigators
- Zhongmin Wang, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882866
- Sponsor's protocol ID
- 2018clinicethicreview215
- Status last verified
- Feb 2020
- First submitted
- 19 Mar 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study
- ClinicalTrials.gov ID
- NCT03882866
- Acronym / sponsor ID
- 2018clinicethicreview215
- Conditions
- Pancreatic Cancer
- Keywords
- Iodine-125, Three-Dimensional Printing, Brachytherapy, template
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Hebei General Hospital, Zhongda Hospital, Anhui Provincial Hospital, The Second Hospital of Shandong University, Sun Yat-sen University, Chinese PLA General Hospital, Huadong Hospital, Tengzhou Central People's Hospital
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 20 Mar 2019 (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.
This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.
Detailed description
Dosimetric verification was performed after implantation. Pre- and postoperative D90, V100, and V150 were calculated. The success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (ORR)，overall survival (OS)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed non-coplanar template | Experimental | Procedure: 3D-printed non-coplanar template3D-printed non-coplanar template is used in this group. |
| 3D-printed coplanar template | Active comparator | Procedure: 3D-printed coplanar template3D-printed coplanar template is used in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: 18-80 years
- Cytologically or histologically confirmed pancreatic adenocarcinoma
- Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)
- Single tumor size≤ 6 cm
- Karnofsky performance score （KPS）≥60
Key exclusion criteria (12 listed)
- Patients with other malignant tumors
- History of other anti-cancer therapy, including surgery,radiation, ablation and so on
- Pregnant or lactating women
- Patients with Immunodeficiency disease
- Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia
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 |
|---|---|---|
| 3D-printed non-coplanar template3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system. | Procedure or surgery | 3D-printed non-coplanar template |
| 3D-printed coplanar template3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system. | Procedure or surgery | 3D-printed coplanar template |
Primary outcome
Objective Response Rate (ORR)
Time frame: 24 months
ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.
3 secondary outcomes
Overall Survival (OS)
Time frame: 24 months
Incidence of treatment-emergent toxicities of two treatment regimens in patients
Time frame: 24 months
Quality of life of two treatment regimens in patients
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Zhongmin Wang, MD principal investigator
Ruijin Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed non-coplanar template and 3D-printed coplanar template in people with Pancreatic Cancer, run by Ruijin Hospital at 8 sites 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 15 inclusion and 12 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Contact Zhongmin Wang, MD (0086-13901848333, wzm0722@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 24 months). 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 6 Feb 2020.