Evaluating surgery for metastatic colon cancer patients

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

This study is testing if surgery to remove the main tumor can help older patients with metastatic colon cancer live longer after they respond well to chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 627 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04416854 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the effectiveness of palliative primary tumor resection in patients with metastatic colon cancer who have shown a positive response to induction chemotherapy based on gene testing. It focuses on patients with initially unresectable metastases and evaluates overall survival as the primary endpoint. The intervention includes surgical resection of the primary tumor along with chemotherapy regimens XELOX and mFOLFOX6. The study is designed for patients aged 75 and older with specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are patients aged 75 or older with a diagnosis of colon cancer adenocarcinoma and a positive response to chemotherapy.

Not a fit: Patients requiring immediate surgical intervention for complications like perforation or obstruction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve overall survival for patients with metastatic colon cancer.

How similar studies have performed: Other studies have explored palliative surgeries in cancer treatment, but this specific approach is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Xinxiang Li

Conditions: Metastatic Colon Cancer, Surgery, palliative surgery, stage IV colon cancer, chemotherapy