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

Who is this study for? Adult patients with Colon Adenocarcinoma
What treatments are being studied? Surgical Resection
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xinxiang Li
1149lxx@sina.com
+8613761291659
Backup
Qingguo Li
qingguoli@fudan.edu.cn
+8618918298120
Time Frame
Start Date: 2020-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 627
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov