CTV Exploration of 3D-PT Assisted CT-guided I-125 Seeds Implantation for Recurrent Rectal Cancer

January 13, 2021 updated by: Peking University Third Hospital

Clinical Target Volume Exploration of 3D Printing Personalized Template Assisted CT-guided Radioactive Iodine-125 Seeds Implantation as a Salvage Treatment for Recurrent Rectal Cancer Patients After Operation and Radiotherapy

This study is to explore the progression-free survival time (PFS) , overall survival time (OS), quality of life and side effects between two different clinical target volumes in the treatment of 3D printing template-assisted CT-guided radioactive iodine-125 seeds implantation for recurrent rectal cancer after surgery and radiotherapy and investigate the clinical and dosimetric prognosis factors for outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

From June 2019 to December 2020 in each participating center, patients with recurrent rectal cancer after surgery and radiotherapy will be included in the study if they meet the inclusion criteria and do not meet the exclusion criteria. According to the clinical conditions of the patients, they will be assigned to groups A or B according to the doctor's recommendations and their own wishes. GTV of both groups are visible tumors. The CTV of group A is expanded by 3mm on the basis of GTV, and the CTV of group B is expanded by 6mm. Both groups A and B received prescription dose: 95% GTV (120-160) Gy, 95% CTV (90-120) Gy. The activities of 125I seeds will be 0.4mCi-0.7mCi. All patients will receive 3D printed template-assisted 125I seeds implantation and be followed up. The differences in local progression-free survival time, overall survival time, change of quality of life, and side effects between different groups will be prospectively analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking Unnversity Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recurrent rectal cancer after surgery and radiotherapy who will receive 3D-PT Assisted CT-guided I-125 Seeds Implantation

Description

Inclusion Criteria:

  • KPS score above 60;
  • Age from 18 to 80 years old;
  • Rectal cancer by histological diagnosis, recurrence after surgery and radiotherapy;
  • The diameter of the lesion ≤ 5cm;
  • The tumor has not invaded the intestines or bladder;
  • The estimated survival time is more than 3 months;
  • The percutaneous puncture path is feasible and the preoperative plan can meet the prescription dose;
  • Blood routine, liver, kidney and other major organ functions: WBC is normal, PLT≥100×109/L, HGB≥100g/L; urea nitrogen, creatinine≤1.25×upper limit of normal (UNL), ALT (SGPT) and AST (SGOT) ≤2.5×UNL; ECG is basically normal;
  • Recurrence in pelvic region after surgery and radiotherapy for various reasons; or oligo-metastatic lesions less than 3, which are stable with treatment. Except for rectal incision stump and recurrence at the anastomosis.

Exclusion Criteria:

  • Major organ failure, decompensated heart and lung failure such as congestive heart failure, coronary heart disease with clinical symptoms, and arrhythmia that cannot be controlled by drugs;
  • Patients with other serious uncontrollable medical diseases;
  • Severe coagulation dysfunction;
  • With serious infection or ulcer at the puncture site;
  • Pregnancy, breastfeeding women, children and mental patients;
  • Patients with severe diabetes;
  • Cases that invade large blood vessels and vital organs, which may cause hemorrhage and severe organ dysfunction;
  • Those who have participated in clinical trials of other drugs or medical devices before being selected but have not reached the time limit of the main research endpoint or have completed clinical trials of other drugs or medical devices for less than 4 weeks;
  • Poor compliance and unable to complete the course of treatment;
  • Other reasons the researchers think it is inappropriate to participate in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CTV 3mm
CTV is expanded by 3mm on the basis of GTV.
CTV 6mm
CTV is expanded by 6mm on the basis of GTV.
Radiation: CTV
According to the clinical conditions of the patients, they will be assigned to two groups based on the doctor's recommendations and their own wishes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival time (PFS)
Time Frame: 3 years
The time from 125I radioactive seeds implantation to local failure or death.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival time (OS)
Time Frame: 3 years
The time from 125I radioactive seeds implantation to death due to any cause.
3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Karnosky Score
Time Frame: 3 years
This is a functional status score, which is one of the methods to evaluate the quality of life. The range is from 0-100 points. The higher the score, the better the functional status and the higher the quality of life are.
3 years
Visual Analogue Score
Time Frame: 3 years
This is a pain score ,which is one of the evaluation indicators of quality of life. The range is 0-10 points. The higher the score, the higher the pain and the worse the quality of life are.
3 years
Side effects
Time Frame: 3 years
Difined and classified by RTOG
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTV of 125I for rectal cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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