Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy - Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal CancerReport as inadecuate




Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy - Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer - Download this document for free, or read online. Document in PDF available to download.

Reference: Virdee, P, Moschandreas, J, Gebski, V et al., (2017). Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. Journal of Medical Internet Research, 6 (3).Citable link to this page:

 

Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer

Abstract: Background: In colorectal cancer (CRC), unresectable liver metastases are associated with a poor prognosis. The FOXFIRE (an open-label randomized phase III trial of 5-fluorouracil, oxaliplatin, and folinic acid +/- interventional radioembolization as first-line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer), SIRFLOX (randomized comparative study of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma), and FOXFIRE-Global (assessment of overall survival of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma in a randomized clinical study) clinical trials were designed to evaluate the efficacy and safety of combining first-line chemotherapy with selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres, also called transarterial radioembolization.Objective: The aim of this analysis is to prospectively combine clinical data from 3 trials to allow adequate power to evaluate the impact of chemotherapy with SIRT on overall survival.Methods: Eligible patients are adults with histologically confirmed CRC and unequivocal evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. Patients may also have limited extrahepatic metastases. Final analysis will take place when all participants have been followed up for a minimum of 2 years.Results: Efficacy and safety estimates derived using individual participant data (IPD) from SIRFLOX, FOXFIRE, and FOXFIRE-Global will be pooled using 2-stage prospective meta-analysis. Secondary outcome measures include progression-free survival (PFS), liver-specific PFS, health-related quality of life, response rate, resection rate, and adverse event profile. The large study population will facilitate comparisons of low frequency adverse events and allow for more robust safety analyses. The potential treatment benefit in those patients who present with disease confined to the liver will be investigated using 1-stage IPD meta-analysis. Efficacy will be analyzed on an intention-to-treat basis.Conclusions: This analysis will assess the impact of SIRT combined with chemotherapy on overall survival in the first-line treatment of metastatic CRC. If positive, the results will change the standard of care for this disease.

Publication status:PublishedPeer Review status:Peer reviewedVersion:Publisher's versionDate of acceptance:2017-01-21 Funder: Cancer Research UK   Funder: Sirtex Medical Ltd   Funder: National Institute for Health Research   Notes:©Pradeep S Virdee, Joanna Moschandreas, Val Gebski, Sharon B Love, E Anne Francis, Harpreet S Wasan, Guy van Hazel, Peter Gibbs, Ricky A Sharma. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.03.2017. This is an open-access article distributed under the terms of the Creative Commons Attribution License 2.0.

Bibliographic Details

Publisher: JMIR Publications

Publisher Website: http://jmirpublications.com/

Journal: Journal of Medical Internet Researchsee more from them

Publication Website: http://www.jmir.org/

Volume: 6

Issue: 3

Issue Date: 2017-03-08Identifiers

Doi: https://doi.org/10.2196/resprot.7201

Issn: 1439-4456

Eissn: 1438-8871

Uuid: uuid:d7834a1f-55f2-4fa0-bb88-c5ae32026403

Urn: uri:d7834a1f-55f2-4fa0-bb88-c5ae32026403

Pubs-id: pubs:687291 Item Description

Type: journal-article;

Version: Publisher's versionKeywords: colorectal neoplasms liver neoplasm metastasis radiation oncology survival analysis meta-analysis

Relationships





Author: Virdee, P - institutionUniversity of Oxford Oxford, MSD, NDORMS, CSM - - - Moschandreas, J - institutionUniversity of Oxford Oxfo

Source: https://ora.ox.ac.uk/objects/uuid:d7834a1f-55f2-4fa0-bb88-c5ae32026403



DOWNLOAD PDF




Related documents