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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Metastatic Colon Cancer
• Intervention / Treatment: Procedure: resection of primary tumor; Drug: XELOX; Drug: mFOLFOX6

• Study Type: Interventional
• Enrollment (Anticipated): 627
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xinxiang Li; Phone Number: +8613761291659; Email: 1149lxx@sina.com
• Study Contact Backup: Name: Qingguo Li; Phone Number: +8618918298120; Email: qingguoli@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Xinxiang Li, MD,PhD
      • Contact: Xinxiang Li, MD,PhD; Phone Number: +8613918176716; Email: lxx1149@163.com
      • Contact: Qingguo Li, MD,PhD; Phone Number: +8618918298120; Email: qingguoli@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemotherapy plus surgery; 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.	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; Drug: mFOLFOX6; Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
Active Comparator: Chemotherapy alone; 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.	Drug: XELOX; Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle; Drug: mFOLFOX6; Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of adverse events resulted from chemotherapy	The ratio of the number of patients experienced adverse events to the total patients	3-year
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
Objective response rate		1-year
Progression-free survival 1	The first progression time after diagnosis	3-year
Progression-free survival 2	The first progression time after randomization	3-year
The rate of postoperative complications	The ratio of the number of patients with postoperative complications to the total patients	1-year
The proportion of surgical intervention in control group		1-year

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: chemotherapy; stage IV colon cancer; palliative surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: FDPRMCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No