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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Neoplasms Neoplasm Metastasis Liver Neoplasms Chemotherapy; Maternal, Affecting Fetus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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arm A

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

Group Type EXPERIMENTAL

chemotherapy ± targeted therapy

Intervention Type DRUG

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

arm B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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chemotherapy ± targeted therapy

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

Intervention Type DRUG

Other Intervention Names

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chemotherapy plus targeted therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No