Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Herbal and Botanical

Bevacizumab

Liver Extracts

Cola

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.

FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study

OS defined as the time interval between the date of randomization and the date of death from any cause.

PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.

Sirtex Medical

Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment.

Of the 105 in 'mFOLFOX6 Plus SIRT' arm, 3 did not get any treatment,10 received mFOLFOX6 without SIRT. Hence safety population in this arm comprises 92 participants.

The 'mFOLFOX6 alone' arm comprised 104 participants, 2 did not receive any treatment and safety population in this arm comprises 112 participants including the 10 participants that received mFOLFOX6 without SIRT.

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

FOLFOX6m

SIR-Spheres microspheres

mFOLFOX6 Plus SIRT

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

FOLFOX6m

mFOLFOX6 Alone

Total

Age, Continuous

Age, Categorical

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

(0) Able to carry out all normal activity without restriction

(1) Restricted in physically strenuous activity but ambulatory and able to carry out light work

WHO performance status

Extra-hepatic Disease

<=25%

>25%

Liver Involvement %

Tumor volume

ITT bevacizumab

Janet Bell, M.B.A.

The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.

Overall Survival (OS)

A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.

Progression-free Survival

Overall Study

Spots Global Cancer Trial Database for folfox6m

Every month we try and update this database with for folfox6m cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for folfox6m

Every month we try and update this database with for folfox6m cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for folfox6m cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.