Clinical trial NCT01307878: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Chemotherapy; Maternal, Affecting Fetus
Keywords: Unresectable colorectal liver metastases
Pre-operation chemotherapy
Primary tumor resection
Survival
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Ruijin Hospital
name: Changhai Hospital
First posted: 2011-03-03
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 3 years
measure: Tumor response
timeFrame: Up to 6 months
measure: Secondary resection rate Second radical resectability
timeFrame: Up to 6 months
measure: Surgical complications
timeFrame: 30 days after surgery
measure: Toxicity of chemotherapy
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu, Ph.D., M.D
role: STUDY_CHAIR
References: