New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases
- Conditions
- Neoplasm MetastasisColorectal NeoplasmsLiver NeoplasmsChemotherapy; Maternal, Affecting Fetus
- Interventions
- Drug: chemotherapy ± targeted therapy
- Registration Number
- NCT01307878
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm A chemotherapy ± targeted therapy Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
- Primary Outcome Measures
Name Time Method Progression-free survival Up to 3 years Time from randomization to the date of disease progression or to death of any cause
- Secondary Outcome Measures
Name Time Method Tumor response Up to 6 months Response according to RECIST 1.1
Surgical complications 30 days after surgery The proportion of patients with any complications occurred within 30 days after surgery
Overall survival Up to 3 years Time from randomization to death from any cause or the date of the last follow-up
Secondary resection rate Second radical resectability Up to 6 months The rate of patients converted to resection for liver metastases
Toxicity of chemotherapy Up to 6 months Patients will be evaluated for Adverse Events at the start of each treatment cycle according to NCI CTC 3.0 criteria
Trial Locations
- Locations (1)
Zhongshan hospital, Fudan university
🇨🇳Shanghai, Shanghai, China