The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

Phase 3

Recruiting

• Conditions: Surgery; Metastatic Colon Cancer
• Interventions: Procedure: resection of primary tumor; Drug: XELOX; Drug: mFOLFOX6

• Registration Number: NCT04416854
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-05-26
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-01
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 627

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy plus surgery	mFOLFOX6	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.
Chemotherapy plus surgery	resection of primary tumor	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.
Chemotherapy alone	mFOLFOX6	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.
Chemotherapy plus surgery	XELOX	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.
Chemotherapy alone	XELOX	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	5-year

Secondary Outcome Measures

Name	Time	Method
Progression-free survival 2	3-year	The first progression time after randomization
Objective response rate	1-year
The proportion of surgical intervention in control group	1-year
The rate of adverse events resulted from chemotherapy	3-year	The ratio of the number of patients experienced adverse events to the total patients
Progression-free survival 1	3-year	The first progression time after diagnosis
The quality of life postoperatively	3-month, 6-month, 9-month, 12-month, 18-month, 24-month	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
The rate of postoperative complications	1-year	The ratio of the number of patients with postoperative complications to the total patients

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China