Clinical trial · Interventional
CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC
Curative Chemoradiotherapy Versus Radical Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of Colorectal Cancer
NCT03725254CI-TRIAL-00036685unknownPhase 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 study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer patients.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Para-aortic Lymph Node Metastasis | — | UNRESOLVED | — |
| Retroperitoneal Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiotherapy | Radiation | — | UNRESOLVED |
| lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- radical surgery
- description
- In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.
- interventionNames
- Procedure: lymphadenectomy
- type
- EXPERIMENTAL
- label
- radical chemoradiotherapy
- description
- In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
- interventionNames
- Radiation: chemoradiotherapy
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * A medical history of colorectal cancer * Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins. * The treatment target is no evidence of disease (NED), including 3 cohorts: A. Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED) * ECOG PS 0-2 * Ability to follow the program during the study period * Signing written informed consent Exclusion Criteria: * Retroperitoneal LN metastasis is above the level of the renal vein. * Unable to reach NED. * Previous pelvic radiotherapy, the field of irradiation overlaps with this time. * Pregnancy or breastfeeding women. * Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. * If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance. * Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months * Organ transplantation requires immunosuppressive therapy * Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases * Subjects Blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets ≥ 100 × 109 / L; ALT, AST≤2.5 times normal upper limit; ALP≤2.5 times normal upper limit; serum total bilirubin \<1.5 times normal upper limit; serum creatinine \<1 times normal upper limit; serum albumin ≥30g/L
References
Publications (0)
Data not yet available
No reference posted for this study.