Clinical trial · Interventional
Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
NCT02423226CI-TRIAL-00017609completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed tomography guided radioactive seeds implant | Procedure | — | UNRESOLVED |
| Systemic chemotherapy (FOLFIRI) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CT alone
- description
- Treated with systemic chemotherapy alone (FOLFIRI).
- interventionNames
- Drug: Systemic chemotherapy (FOLFIRI)
- type
- EXPERIMENTAL
- label
- CT+BT
- description
- Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant.
- interventionNames
- Procedure: Computed tomography guided radioactive seeds implant
- Drug: Systemic chemotherapy (FOLFIRI)
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy * Second-line treatment for advanced colorectal cancer,irinotecan was not previously used. * Age range 18-70 years old * ECOG performance status 0-1 * Life expectancy of more than 3 months * Adequate organ function Exclusion Criteria: Previous serious cardiac disease * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Pregnant or lactating women * Chronic inflammatory bowel disease or intestinal obstruction * Serious uncontrolled diseases and intercurrent infection
References
Publications (0)
Data not yet available
No reference posted for this study.