Clinical trial · Observational
CTV Exploration of 3D-PT Assisted CT-guided I-125 Seeds Implantation for Recurrent Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 125I Seeds Implantation | — | UNRESOLVED | — |
| Clinical Target Volume | — | UNRESOLVED | — |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTV | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CTV 3mm
- description
- CTV is expanded by 3mm on the basis of GTV.
- label
- CTV 6mm
- description
- CTV is expanded by 6mm on the basis of GTV.
- interventionNames
- Radiation: CTV
Primary outcomes (1)
- measure
- Progression free survival time (PFS)
- timeFrame
- 3 years
- description
- The time from 125I radioactive seeds implantation to local failure or death.
Secondary outcomes (1)
- measure
- Overall survival time (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available