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

Fudan University320 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

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

Interventions

chemotherapy ± targeted therapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Progression-free survival

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

Time frame: Up to 3 years

Secondary Outcomes

Overall survival

Time from randomization to death from any cause or the date of the last follow-up

Time frame: Up to 3 years

Tumor response

Response according to RECIST 1.1

Time frame: Up to 6 months

Secondary resection rate Second radical resectability

The rate of patients converted to resection for liver metastases

Time frame: Up to 6 months

Surgical complications

The proportion of patients with any complications occurred within 30 days after surgery

Time frame: 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

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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