The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

NCT04416854 | Unknown Phase 3

• 1 other identifier: FDPRMCC
• Study Type: interventional
• Target: 627
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colon Cancer; Surgery

Keywords

palliative surgery; stage IV colon cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5-year

Secondary Outcomes (7)

• Progression-free survival 1

  3-year

• Progression-free survival 2

  3-year

• The rate of adverse events resulted from chemotherapy

  3-year

• The quality of life postoperatively

  3-month, 6-month, 9-month, 12-month, 18-month, 24-month

• Objective response rate

  1-year

Study Arms (2)

Chemotherapy plus surgery

EXPERIMENTAL

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; Drug: XELOX; Drug: mFOLFOX6

Chemotherapy alone

ACTIVE COMPARATOR

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; Drug: mFOLFOX6

Interventions

resection of primary tumor PROCEDURE

resection of primary lesion with unresectablely metastatic colon cancer

Chemotherapy plus surgery

XELOX DRUG

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

Chemotherapy alone; Chemotherapy plus surgery

mFOLFOX6 DRUG

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

Chemotherapy alone; Chemotherapy plus surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Xinxiang Li

CONTACT

+8613761291659; 1149lxx@sina.com

Qingguo Li

CONTACT

+8618918298120; qingguoli@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: April 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

CN (1)