Know Cancer

forgot password

Phase II Clinical Trial of Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

Thank you

Trial Information

Phase II Clinical Trial of Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer

No previous treatment.

The 21 day cycle of treatment will be given for four courses before being reassessed by
MRI/CT for resectability of their liver metastases.

Those patients with stable disease or partial response, but are not yet resectable will
continue for a further four courses of treatment before reassessment.

Patients whose liver metastases have become resectable will proceed to surgery after a 6
week break from the last administration of Capecitabine (8 weeks from the last
administration of Bevacizumab).

A further four courses of treatment will be administered post-operatively to commence at
least 8 weeks after surgery and when the patient is well recovered and healed.

Inclusion Criteria:

- Histologically proven diagnosis of colorectal adenocarcinoma

- Metastatic disease present in the liver only.

- Absence of extrahepatic metastases excluded by CT chest, abdomen and pelvis.
Indeterminate CT findings may require verification by FDG-PET scanning.

- Liver-only metastases determined to be unresectable at presentation on a
pre-treatment liver MRI with an appropriate liver specific contrast (eg. TESLA) by a
specialist multidisciplinary team (consisting of medical oncologist, hepatic surgeon
and radiologist). Guidelines for determining unresectability include:

- presence of >4 metastases;

- size >5cm;

- location and distribution of metastatic disease within the liver unsuitable for
resection with clear margins (eg. Involvement of both lobes of liver; invasion of
intrahepatic vascular structures);

- extent of liver involvement precluding resection with adequate post-resection
residual liver parenchyma volume for viable liver function in the immediate
post-operative period;

- inability to retain adequate vascular in flow and out flow to maintain viable liver

- No previous treatment for metastatic colorectal cancer, including chemotherapy,
targeted or experimental therapies (e.g. anti-VEGF or anti-EGFR), radiotherapy to the
liver, or surgery or radiofrequency ablation to liver metastases.

- Feasibility of surgery with curative intent:

- If the primary colorectal tumour is in situ, the primary tumour must also be
resectable with curative intent

- Patients presenting with liver metastases only relapse after initially curative
resection of their primary colorectal cancer followed by treatment with adjuvant
chemotherapy may not be entered into the study if the relapse has occurred within 12
months of completion of adjuvant treatment

- Adequate medical fitness to undergo neoadjuvant treatment and surgery with curative
intent (hepatectomy +/- resection of primary tumour, if required)

- Absence of pre-existing liver dysfunction of Childs Pugh Grade B or greater. Patients
who are suspected of having pre-existing liver dysfunction due to clinical,
biochemical or radiological findings, should have significant liver disease excluded
by a liver biopsy prior to study entry.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rates

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2006

Completion Date:

December 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis