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A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis

Phase 3
18 Years
75 Years
Open (Enrolling)
Colorectal Cancer, Resectable Liver Metastasis

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Trial Information

A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis

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.

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

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival rate

Outcome Time Frame:

3 year

Safety Issue:


Principal Investigator

Shan Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University People's Hospital, Department of General Surgery


China: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

June 2015

Related Keywords:

  • Colorectal Cancer
  • Resectable Liver Metastasis
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms