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New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
chemotherapy ± targeted therapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Unresectable colorectal liver metastases, Pre-operation chemotherapy, Primary tumor resection, Survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 - 75 years old
  • colorectal adenocarcinoma pathologically
  • without any chemotherapy or radiotherapy
  • unresectable liver metastasis and without other metastasis
  • resectable colorectal cancer
  • suitable for chemotherapy
  • agreed by patients

Exclusion Criteria:

  • age below 18 years old or greater than 75 years old
  • haven't pathological diagnosis of colorectal adenocarcinoma
  • with any chemotherapy or radiotherapy
  • resectable liver metastasis or without other metastasis
  • unresectable colorectal cancer
  • unsuitable for chemotherapy
  • not agreed by patients

Sites / Locations

  • Zhongshan hospital, Fudan university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

arm A

arm B

Arm Description

Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

Outcomes

Primary Outcome Measures

Progression-free survival
Time from randomization to the date of disease progression or to death of any cause

Secondary Outcome Measures

Overall survival
Time from randomization to death from any cause or the date of the last follow-up
Tumor response
Response according to RECIST 1.1
Secondary resection rate Second radical resectability
The rate of patients converted to resection for liver metastases
Surgical complications
The proportion of patients with any complications occurred within 30 days after surgery
Toxicity of chemotherapy
Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria

Full Information

First Posted
March 2, 2011
Last Updated
June 12, 2022
Sponsor
Fudan University
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Ruijin Hospital, Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01307878
Brief Title
New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases
Official Title
Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Ruijin Hospital, Changhai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.
Detailed Description
Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Chemotherapy; Maternal, Affecting Fetus
Keywords
Unresectable colorectal liver metastases, Pre-operation chemotherapy, Primary tumor resection, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm A
Arm Type
Experimental
Arm Description
Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
Arm Title
arm B
Arm Type
No Intervention
Arm Description
Upfront PTR, then chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
Intervention Type
Drug
Intervention Name(s)
chemotherapy ± targeted therapy
Other Intervention Name(s)
chemotherapy plus targeted therapy
Intervention Description
Chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Time from randomization to the date of disease progression or to death of any cause
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from randomization to death from any cause or the date of the last follow-up
Time Frame
Up to 3 years
Title
Tumor response
Description
Response according to RECIST 1.1
Time Frame
Up to 6 months
Title
Secondary resection rate Second radical resectability
Description
The rate of patients converted to resection for liver metastases
Time Frame
Up to 6 months
Title
Surgical complications
Description
The proportion of patients with any complications occurred within 30 days after surgery
Time Frame
30 days after surgery
Title
Toxicity of chemotherapy
Description
Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 - 75 years old colorectal adenocarcinoma pathologically without any chemotherapy or radiotherapy unresectable liver metastasis and without other metastasis resectable colorectal cancer suitable for chemotherapy agreed by patients Exclusion Criteria: age below 18 years old or greater than 75 years old haven't pathological diagnosis of colorectal adenocarcinoma with any chemotherapy or radiotherapy resectable liver metastasis or without other metastasis unresectable colorectal cancer unsuitable for chemotherapy not agreed by patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, Ph.D., M.D
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan hospital, Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases

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