The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416854
• Other study ID #: FDPRMCC
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2020
• Source: Fudan University
• Contact: Xinxiang Li
• Phone: +8613761291659
• Email: 1149lxx[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 627
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Metastatic Colon Cancer
• Surgery

Intervention

Procedure:
• resection of primary tumor
resection of primary lesion with unresectablely metastatic colon cancer

Drug:
• XELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
• mFOLFOX6
Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1,2400 mg/m2 CIV 46h, d1

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5-year
Secondary	Progression-free survival 1	The first progression time after diagnosis	3-year
Secondary	Progression-free survival 2	The first progression time after randomization	3-year
Secondary	The rate of adverse events resulted from chemotherapy	The ratio of the number of patients experienced adverse events to the total patients	3-year
Secondary	The quality of life postoperatively	The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24	3-month, 6-month, 9-month, 12-month, 18-month, 24-month
Secondary	Objective response rate		1-year
Secondary	The rate of postoperative complications	The ratio of the number of patients with postoperative complications to the total patients	1-year
Secondary	The proportion of surgical intervention in control group		1-year