Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Herbal and Botanical

Oxaliplatin

Leucovorin

Fluorouracil

Capecitabine

Cola

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: 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.

resection of primary lesion with unresectablely metastatic colon cancer

resection of primary tumor

Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle

XELOX

Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1

mFOLFOX6

Xinxiang Li

Qingguo Li

Xinxiang Li, MD,PhD

Qingguo Li, MD,PhD

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.

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 first progression time after diagnosis

The first progression time after randomization

The ratio of the number of patients experienced adverse events to the total patients

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 ratio of the number of patients with postoperative complications to the total patients

Fudan University

Professor

Rectal Diseases

Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.

Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.

Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'

Surgical resection of primary tumor

Gong Chen, Prof.

Rong-Xin Zhang, M.D.

Yu-Hong Li, M.D.

Ling-Hneg Kong, M.D.

Zhi-qiang Wang, PhD.

Xiao-Jun Wu, M.D.

Zhi-Zhong Pan, M.D.

Yan-Hong Deng, M.D.

Hui Wang, M.D.

Meng Qiu, M.D.

Zhi-zhong Pan, Prof.

De-Sen Wan, Prof.

There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.

Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients

Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer	NCT04416854	Metastatic Colo... Surgery	resection of pr... XELOX mFOLFOX6	18 Years - 75 Years	Fudan University
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients	NCT02149784	Colorectal Canc...	Surgical resect...	18 Years - 75 Years	Sun Yat-sen University
The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer	NCT04416854	Metastatic Colo... Surgery	resection of pr... XELOX mFOLFOX6	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for resection of primary tumor