Clinical trial · Interventional
New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases
Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases
NCT01307878CI-TRIAL-00059083completedPhase 3ClinicalTrials.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)
To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy; Maternal, Affecting Fetus | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy ± targeted therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- arm A
- description
- Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
- interventionNames
- Drug: chemotherapy ± targeted therapy
- type
- NO_INTERVENTION
- label
- arm B
- description
- Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Up to 3 years
- description
- Time from randomization to the date of disease progression or to death of any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 - 75 years old * colorectal adenocarcinoma pathologically * without any chemotherapy or radiotherapy * unresectable liver metastasis and without other metastasis * resectable colorectal cancer * suitable for chemotherapy * agreed by patients Exclusion Criteria: * age below 18 years old or greater than 75 years old * haven't pathological diagnosis of colorectal adenocarcinoma * with any chemotherapy or radiotherapy * resectable liver metastasis or without other metastasis * unresectable colorectal cancer * unsuitable for chemotherapy * not agreed by patients
References
Publications (0)
Data not yet available
No reference posted for this study.