CTV Exploration of 3D-PT Assisted CT-guided I-125 Seeds Implantation for Recurrent Rectal Cancer
NCT ID: NCT04710589
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2020-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CTV 3mm
CTV is expanded by 3mm on the basis of GTV.
No interventions assigned to this group
CTV 6mm
CTV is expanded by 6mm on the basis of GTV.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Locations
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Peking Unnversity Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTV of 125I for rectal cancer
Identifier Type: -
Identifier Source: org_study_id
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