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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033283
Enrollment
Unknown
Registered
2020-05-26
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

Control group :Chemotherapy alone

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~75 years; 2. ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more; 3. Pathological diagnosis of colon cancer adenocarcinoma; 4. At least one measurable objective tumor lesions which could be evaluated; 5. Primary and metastatic tumors exist at the same time, and distant metastases are not resectable; 6. ANC >= 1.5*10^9/L, PLT>= 90*109/L, HB>= 90g/L, TBI<= 1.5(UNL); ALT, AST <= 2.5(ULN), Cr <= 1.0(ULN) screening within 7 days; 7. No systemic chemotherapy; 8. Patients with voluntary participation, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Operation intervention required for perforation, bleeding and obstruction of intestinal cavity; 2. Multiple primary colorectal carcinoma; 3. Malignant peritoneal effusion or metastatic carcinoma of the peritoneum; 4. Uncontrolled pleural effusion; 5. 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; 6. With brain metastasis or meningeal metastasis; 7. Pregnancy or breast-feeding women; 8. Alcohol or drug addictions; 9. 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.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
The first progression time after diagnosis;The first progression time after randomization;Tolerance to treatment;Living quality;Objective response rate;Postoperative complications;The proportion of surgical intervention in control group;The detection of tumor biomarker and survival analysis;

Countries

China

Contacts

Public ContactXinxiang Li

Shanghai Cancer Center, Fudan University

1149lxx@sina.com+86 13761291659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026