Clinical trial NCT00630045: Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
Official title: A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Resectable Liver Metastasis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
name: Sanofi
First posted: 2008-03-06
Enrollment: 392
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: This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .

Detailed description: Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. )
2. Liver metastasis should be resected with R0 resection and to save enough normal liver tissue
3. Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50%
4. No metastasis of other organs or lymph nodes in abdominal cavity
5. No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months
6. Age 18 to 75 years old
7. Karnofsky performance status ≥70
8. Life expectancy of ≥3 month
9. Bilirubin level \< 1.5mg/dL
10. Serum creatinine \<1.0 times ULN
11. Absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
12. Having signed informed consent

Exclusion Criteria:

1. previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months.
2. No R0 resection or not enough normal liver tissue left
3. previous radiotherapy of target lesions
4. accompanied with unresectable other metastasis or malignant pleural fluids or ascites.
5. complete or uncompleted liver obstruction
6. peripheral neuropathy(NCI-CTC grade 1 or more)
7. mental disturbance neuropathy that influence the cognition, including brain metastasis
8. other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months
9. Other previous malignancy within 5 year, except non-melanoma skin cancer
10. accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials.
11. Pregnancy or lactation period

Primary outcomes:
measure: disease free survival rate
timeFrame: 3 year
Secondary outcomes:
measure: R0 resection rate
timeFrame: at the time of pathological report
measure: survival rate and over survival
timeFrame: 5 year
measure: surgery related mortality
timeFrame: peri-operation period
measure: response rate and safety of XELOX as a neoadjuvant regimen
timeFrame: no time frame
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University, School of Oncology
state: Beijing
city: Beijing
country: China
facility: Peking University, People's Hospital
Study officials:
affiliation: Peking University People's Hospital, Department of General Surgery
name: Shan Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University, School of Oncology, Department of GI Oncology
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: