The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04416854

Collaborator

(none)

627

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colon Cancer Surgery	Procedure: resection of primary tumor Drug: XELOX Drug: mFOLFOX6	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

627 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall survival [5-year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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≥1.5109/L；PLT≥90109/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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LI XIN-XIANG, Professor, Fudan University

ClinicalTrials.gov Identifier:

NCT04416854

Other Study ID Numbers:

FDPRMCC

First Posted:

Jun 4, 2020

Last Update Posted:

Jun 4, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by LI XIN-XIANG, Professor, Fudan University

palliative surgery

stage IV colon cancer

chemotherapy

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Jun 4, 2020