NCT01307878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

9 years

First QC Date

March 2, 2011

Last Update Submit

June 12, 2022

Conditions

Colorectal NeoplasmsNeoplasm MetastasisLiver NeoplasmsChemotherapy; Maternal, Affecting Fetus

Keywords

Unresectable colorectal liver metastasesPre-operation chemotherapyPrimary tumor resectionSurvival

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Time from randomization to the date of disease progression or to death of any cause

    Up to 3 years

Secondary Outcomes (5)

  • Overall survival

    Up to 3 years

  • Tumor response

    Up to 6 months

  • Secondary resection rate Second radical resectability

    Up to 6 months

  • Surgical complications

    30 days after surgery

  • Toxicity of chemotherapy

    Up to 6 months

Study Arms (2)

arm A

EXPERIMENTAL

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

Drug: chemotherapy ± targeted therapy

arm B

NO INTERVENTION

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

Interventions

chemotherapy ± targeted therapyDRUG

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

Also known as: chemotherapy plus targeted therapy
arm A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisLiver Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jianmin Xu, Ph.D., M.D

    Fudan University

    STUDY CHAIR

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

March 2, 2011

First Posted

March 3, 2011

Study Start

June 1, 2012

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations

CN(1)