Clinical trial · Interventional
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial
NCT04416854CI-TRIAL-00045410unknownPhase 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)
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.
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 |
|---|---|---|---|
| Metastatic Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFOX6 | Drug | — | UNRESOLVED |
| resection of primary tumor | Procedure | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy plus surgery
- description
- Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
- interventionNames
- Procedure: resection of primary tumor
- Drug: XELOX
- Drug: mFOLFOX6
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy alone
- description
- Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
- interventionNames
- Drug: XELOX
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 75 years old * ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more * Pathological diagnosis of colon cancer adenocarcinoma * At least one measurable objective tumor lesions which could be evaluated. * Primary and metastatic tumors exist at the same time, and distant metastases are not resectable * ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days * No systemic chemotherapy * Patients with voluntary participation, and sign the informed consent Exclusion Criteria: * Operation intervention required for perforation, bleeding and obstruction of intestinal cavity * Multiple primary colorectal carcinoma * Malignant peritoneal effusion or metastatic carcinoma of the peritoneum * Uncontrolled pleural effusion * Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas * With brain metastasis or meningeal metastasis * Pregnancy or breast-feeding women * Alcohol or drug addictions * There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation
References
Publications (0)
Data not yet available
No reference posted for this study.