Avastin in Combination With Chemotherapy for RAS Mutant Unresectable Colorectal Liver-limited Metastases

NCT01972490 | Completed Phase 4 DMC

• 1 other identifier: ACCMCLM
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators assessed the effect of avastin in combination with chemotherapy in the treatment of RAS mutant-type, unresectable colorectal liver-limited metastases

Conditions

Colorectal Neoplasms

Keywords

colorectal neoplasms; liver metastasis; chemotherapy; avastin

Outcome Measures

Primary Outcomes (1)

• the rate of patients converted to resection for liver metastases

  To explore whether avastin in combination with chemotherapy as treatment could improve the resection rate in patients with RAS mutant-type, unresectable colorectal liver-limited metastases compared with chemotherapy alone.

  3 years

Secondary Outcomes (3)

• progression free survival

  3 years

• overall survival

  3 years

• tumor response

  3 years

Study Arms (2)

ARM A

EXPERIMENTAL

patients received avastin in combination with mFOLFOX6

Drug: avastin; Drug: mFOLFOX6

ARM B

ACTIVE COMPARATOR

Patients received mFOLFOX6 alone

Drug: mFOLFOX6

Interventions

avastin DRUG

Drug: avastin On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of avastin (5mg/kg) followed by chemotherapy of mFOLFOX6 until progressive disease or unacceptable toxicity.

Also known as: Bevacizumab

ARM A

mFOLFOX6 DRUG

mFOLFOX-6 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV400mg/m2 on days 1 infused during 2 hours, followed by FU 400 mg/m2 intravenous bolus then 2400 mg/m2 continuous infusion for 46 hours)

ARM A; ARM B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years;
• Primary tumour was histologically confirmed colorectal adenocarcinoma;
• Together with clinical or radiological evidence of first occurrence of non-resectable liver-only metastases
• With evidence of tumor RAS gene mutant status;
• With at least one measurable tumor.
• Performance status (ECOG) 0\~1
• A life expectancy of ≥ 3 months
• Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
• Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
• Written informed consent for participation in the trial.

You may not qualify if:

• Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
• Known or suspected extrahepatic metastases.
• Patients with known hypersensitivity reactions to any of the components of the study treatments.
• Having previously participated in a study which included a possibility of being allocated to avastin therapy (whether or not the patient actually received avastin)
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
• Acute or sub-acute intestinal occlusion
• Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
• Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
• Known drug abuse/ alcohol abuse
• Legal incapacity or limited legal capacity
• Pre-existing peripheral neuropathy.

Sponsors & Collaborators

• Xu jianmin: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Tang W, Ren L, Liu T, Ye Q, Wei Y, He G, Lin Q, Wang X, Wang M, Liang F, Cui Y, Xu J. Bevacizumab Plus mFOLFOX6 Versus mFOLFOX6 Alone as First-Line Treatment for RAS Mutant Unresectable Colorectal Liver-Limited Metastases: The BECOME Randomized Controlled Trial. J Clin Oncol. 2020 Sep 20;38(27):3175-3184. doi: 10.1200/JCO.20.00174. Epub 2020 Aug 4.

  PMID: 32749938 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jianmin Xu, PhD Fudan University

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 30, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

CN (1)