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A Multi-center, Single-arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Neoplasm Metastasis, Colorectal Cancer

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Trial Information

A Multi-center, Single-arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-only Metastases From Colorectal Cancer


Inclusion Criteria:



- Adult Chinese patients, 18-75 years of age

- Histologically confirmed adenocarcinoma in colon or rectum with primary lesion
surgically removed

- Previously untreated unresectable liver-only metastases

- Liver lesions determined to be unresectable by multidisciplinary team (MDT,
consisting of experienced hepatic surgeons, medical oncologist and radiologist).
Guidelines used to determine unresectability includes:

- R0 treatment infeasible with resection

- cannot spare two adjacent liver segments

- retention of liver volume <30%

- vascular flow and biliary drainage cannot be preserved

- No previous treatment against liver metastases, including chemotherapy, surgery,
radiotherapy, TACE and target therapy

- Adequate hematological, renal and hepatic function

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Life expectancy > 3 months

Exclusion Criteria:

- The relapse has occurred within 6 months of completion of the adjuvant treatment

- Expected impossible to achieve R0 resection and/or gain 30% residual liver volume
even with responsive neoadjuvant therapy

- Patient cannot tolerate the surgery

- Other malignancies in the past 5 years, except for curatively treated basal cell
carcinoma of the skin and/or in situ carcinoma of the cervix

- Any extrahepatic metastases and/or recurrence of the primary tumor

- Any residual toxicity from previous chemotherapy (except alopecia) of NCI CTC v.4.0
grade 2

- Hypertension crisis or encephalopathy

- Pregnant or lactating women

- Clinically significant cardiovascular disease

- Evidence of bleeding diathesis or coagulopathy

- Current or recent (within 10 days of study drug initiation) use of full dose of
aspirin, clopidrogel or warfarin

- History or evidence of CNS disease (e-g- primary brain tumor, seizures not controlled
with standard medical therapy, any brain metastases, or history of stroke)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete resection rate (R0) in metastatic colorectal cancer patients with previously unresectable liver-only metastases

Outcome Time Frame:

approximately 3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

China: State Food and Drug Administration (SFDA)

Study ID:

ML28419

NCT ID:

NCT01695772

Start Date:

October 2012

Completion Date:

December 2015

Related Keywords:

  • Neoplasm Metastasis, Colorectal Cancer
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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