Clinical trial · Interventional
Systemic Therapy Sequenced Isolated PALND for mCRC
Curative Systemic Therapy Sequenced Radical Surgery for Synchronous Isolated Paraaortic Lymph Node Metastasis of Colorectal Cancer
NCT04774757CI-TRIAL-00054386unknownN/AClinicalTrials.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 estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.
Conditions
Conditions (2)
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 |
| Synchronous Isolated Para-aortic Lymph Node Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Para-aortic lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Systemic therapy sequenced PALND
- description
- All received systemtic therapy (at most two lines).
- interventionNames
- Procedure: Para-aortic lymph node dissection
Primary outcomes (1)
- measure
- 3-year DFS
- timeFrame
- From date of recruiment until the date of disease recurrece, assessed up to 3 years
- description
- Time with no recurrence of the diseases.
Secondary outcomes (3)
- measure
- 5-year OS
- timeFrame
- Up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age at enrollment is \>= 18 and \<= 75 years 2. ECOG PS 0-1 3. Histologically confirmed colorectal carcinoma 4. Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape. 5. Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED). 6. Adequate liver, renal and bona marrow function. 7. Signing written informed consent Exclusion Criteria: 1. In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis. 2. Unable to achieve NED 3. 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. 4. Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. 5. Organ transplantation requires immunosuppressive therapy
References
Publications (0)
Data not yet available
No reference posted for this study.