Status:
UNKNOWN
CTV Exploration of 3D-PT Assisted CT-guided I-125 Seeds Implantation for Recurrent Rectal Cancer
Lead Sponsor:
Peking University Third Hospital
Conditions:
Recurrent Rectal Cancer
125I Seeds Implantation
Eligibility:
All Genders
18-80 years
Brief Summary
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 pr...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04710589
Start Date
January 1 2020
End Date
December 31 2023
Last Update
January 14 2021
Active Locations (1)
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1
Peking Unnversity Third Hospital
Beijing, Beijing Municipality, China, 100191