SWOG clinical trial number
CTSU/C80405

A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Closed
Published
Abbreviated Title
Colorectal Ph III 5-FU & leucovorin + either irinotecan or oxaliplatin + either bevacizumab, cetuximab, or both
Activated
10/01/2005
Closed
03/01/2012
Participants
CTSU

Research committees

Gastrointestinal Cancer

Treatment

Irinotecan Leucovorin + 5-FU Oxaliplatin Bevacizumab Cetuximab

Eligibility Criteria Expand/Collapse

The Southwest Oncology Group has endorsed this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.

Publication Information Expand/Collapse

2020

Diabetes and Clinical Outcome in Patients with Metastatic Colorectal Cancer: CALGB 80405 (Alliance)

JC Brown;S Zhang;F-S Ou;A Venook;D Niedzwiecki;H-J Lenz;F Innocenti;BH O'Neil;JE Shaw;B Polite;H Hochster;JN Atkins;RM Goldberg;K Ng;RJ Meyer;CD Blanke;E O'Reilly;CS Fuchs;JA Meyerhardt JNCI Cancer Spectrum Feb; 4(1):pkz078

Rural and urban disparities based on zip code of residence: Analyses of 834 and 2159 patients in N9741 and CALGB 80405 trials respectively.

M Malla;L Huebner;S Piawah;H-J Lenz;J Meyerhardt;E O'Reilly;CD Blanke;Q Shi;A Venook;R Goldberg J Clin Oncol 38: 2020 (suppl; abstr e16076); American Society of Clinical Oncology 2020 Annual Meeting, publication only

Predictive and prognostic value of HER2 gene expression and HER2 amplification in patients with metastatic colorectal cancer (mCRC) enrolled in CALGB/SWOG 80405 (Alliance)

F Battaglin;F-S Ou;Z Qu;M Bertagnolli;H Hochster;D Niedzwiecki;R Goldberg;R Mayer;T Zemla;CD Blanke;A Venook;C Bias;O Kabbarah;H-J Lenz;F Innocenti J Clin Oncol 38: 2020 (suppl; abstr 4086); American Society of Clinical Oncology 2020 Annual Meeting, poster

2019

Plasma 25-Hydroxyvitamin D levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings From CALGB/SWOG 80405 (Alliance)

C Yuan;K Sato;B Hollis;S Zhang;D Niedzwiecki;F-S Ou;I-W Chang;BH O'Neil;F Innocenti;H-J Lenz;C Blanke;A Venook;R Mayer;C Fuchs;J Meyerhardt;K Ng Clinical Cancer Research Dec 15;25 (24):7497-7505; Sep 23 [Epub ahead of print]

PMid: PMID31548349 | PMC number: PMC6911644

Mutational analysis of metastatic colorectal cancer patients in CALGB/SWOG 80405 identifies new roles of microsatellite instability and tumor mutational burden for patient outcome

F Innocenti;F-S Ou;X Qu;P Tyler;T Zemla;Niedzwiecki;R Tam;SA Mahajan;RM Goldberg;M Bertaqnolli;CD Blanke;H Sanoff;J Atkins;B Polite;A Venook;H-J Lenz;O Kabbarah Journal of Clinical Oncology May 10;37(14):1217-1227; Mar 13:JCO1801798. doi: 10.1200/JCO.18.01798. [Epub ahead of print]

PMid: PMID30865548 | PMC number: PMC6506418

Body mass index, weight loss, and progression and mortality in metastatic colorectal cancer

B Guercio;S Zhang;A Venook;F-S Ou;D Niedzwiecki;H-J Lenz;F Innocenti;M Mahoney;B O'Neil;JE Shaw;B Polite;H Hochster;JN Atkins;RM Goldberg;RJ Mayer;CD Blanke;CS Fuchs;JA Meyerhardt American Association for Cancer Research (March 29-Apr 3, 2019 Atlanta, Georgia), poster

Impact of Consensus Molecular Subtype (CMS) on Survival in Patients with Metastatic Colorectal Cancer: Results from SWOG/ALLIANCE 80405

H-J Lenz;F-S Ou;A Venook;H Hochster;D Niedzwiecki;R Goldberg;R Mayer;M Bertagnolli;CD Blanke;T Zemla;X Qu;P Wirapati;S Tejpar;F Innocenti;O Kabbarah Journal of Clinical Oncology Aug 1;37(22):1876-1885; May 1[Epub ahead of print]

PMid: PMID31042420 | PMC number: PMC6675593

Diet quality and survival in metastatic colorectal cancer (CRC): data from CALGB/SWOG 80405 (Alliance)

E Van Blarigan;S Zhang;F-S Ou;A Venook;K Ng;C Atreya;D Niedzwiecki;E Giovannucci;H-J Lenz;F Innocenti;BH O'Neil;JE Shaw;B Polite;H Hochster;J Atkins;R Goldberg;RJ Mayer;CD Blanke;E O'Reilly;C Fuchs;J Meyerhardt American Institute for Cancer Research (AICR) Conference (May 15-17, 2019, Chapel Hill, NC), accepted, poster

Associations of Insulin-Like Growth Factor Binding Proteins and Adiponectin with Disease Progression and Mortality in Metastatic Colorectal Cancer: Results from CALGB/SWOG 80405 (Alliance)

B Guercio;A Venook;S Zhang;F-S Ou;D Niedzwiecki;H-J Lenz;F Innocenti;M Pollak;AB Nixon;M Mahoney;B O'Neil;J Shaw;B Polite;CS Denlinger;J Atkins;R Goldberg;R Mayer;CD Blanke;CS Fuchs;J Meyerhardt J Clin Oncol 37(suppl; abstr 3035); American Society of Clinical Oncology (5/31- 6/4/2019, Chicago IL), poster session

Associations of Physical Activity with Survival and Progression in Metastatic Colorectal Cancer: Results from CALGB(Alliance)/SWOG 80405

B Guercio;S Zhang;F-S Ou;A Venook;D Niedzwiecki;H-J Lenz;F Innocenti;B O'Neil;JE Shaw;B Polite;H Hochster;J Atkins;R Goldberg;K Sato;K Ng;E Van Blarigan;RJ Mayer;CD Blanke;E O'Reilly;C Fuchs;J Meyerhardt Journal of Clinical Oncology Oct 10;37(29):2620-2631

PMid: PMID31408415 | PMC number: PMC Journal - In Process

Next-generation sequencing (NGS) in patients (pts) with metastatic colorectal cancer (mCRC): novel mutated genes and differential response to therapy (Alliance)

F Innocenti;N Rashid;M Wancen;F-S Ou;X Qu;S Denning;M Bertagnolli;CD Blanke;A Venook;O Kabbarah;H-J Lenz Annals of Oncology 30 (suppl_5): v198-v252; European Society for Medical Oncology (ESMO), (Sept 27-Oct 1, 2019, Barcelona, Spain),

2018

Association of RAS mutations with race in metastatic colorectal cancer:CALGB/SWOG 80405 (ALLIANCE)

A Sehdev;D Niedzwiecki;A Venook;H-J Lenz;F Innocenti;MR Mahoney;JE Shaw;BN Polite;HS Hochster;JN Atkins;RM Goldberg;RJ Mayer;RL Schilsky;M Bertagnoilli;CD Blanke;B O'Neill Journal of Clinical Oncology 36(suppl 4S; abstr 638); ASCO Gastrointestinal Cancers Symposium 2018 (January 18-20, 2018, San Francisco, CA), poster session

Causal modeling of CALGB 80405 identifies network drivers of metastatic colorectal cancer (CRC)

F Innocenti;H-J Lenz;J Meyerhardt;D Niedzwiecki;A Nixon;E O'Reilly;F-S Ou;A Venook;RK Das;L Furchtgott;D Cunha;K Rich;J Latourelle;D Wuest;B Hayete;I Khalil J Clin Oncol 36, 2018 (suppl; abstr 3570); ASCO Annual Meeting (June 1- 5, 2018, Chicago, IL), poster session

Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension

M Li;F Mulkey;C Jiang;B O'Neil;B Schneider;F Shen;P Friedman;Y Momozawa;M Kubo;D Niedzwiecki;H Hochster;H-J Lenz;JN Atkins;H Rugo;S Halabi;W Kelly;H McLeod;F Innocenti;M Retain;A Venook;K Owzar;D Kroetz Clinical Cancer Research Oct 1;24(19):4734-4744

PMid: PMID29871907 | PMC number: PMC6168379

2017

Associations of physical activity with survival and progression in metastatic colorectal cancer: results from CALGB 80405 (Alliance)

B Guercio;A Venook;D Niedzwiecki;S Zhang;K Sato;C Fuchs;H-J Lenz;F Innocenti;B Fruth;E Van Blarigan;B O'Neil;JE Shaw;B Polite;H Hochster;J Atkins;R Goldberg;R Mayer;M Bertagnolli;C Blanke;J Meyerhardt Journal of Clinical Oncology 35, 2017 (suppl 4S; abstract 659); ASCO GI Cancers Symposium (Jan 19-21, 2017, San Francisco, CA), poster, abst.#659

Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial

A Venook;D Niedzwiecki;H-J Lenz;F Innocenti;B Fruth;JA Meyerhardt;D Schrag;C Greene;BH O'Neil;JE Shaw;JN Atkins;AB El-Khoueiry;S Berry;B Polite;EM O'Reilly;R Goldberg;H Hochster;R Schilsky;M Bertagnolli;RJ Mayer;CD Blanke Journal of the American Medical Association Jun 20;317(23):2392-2401

PMid: PMID28632865 | PMC number: PMC5545896

Primary tumor location is an independent prognostic maker from CMS and MSI for overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB / SWOG 80405 (Alliance)

A Venook;FS Ou;F Innocenti;H Hochster;D Niedzwiecki;R Goldberg;R Mayer;M Bertagnolli;C Blanke;T Zemla;X Qu;O Kabbarah;H Lenz J Clin Oncol 35, 2017 (suppl; abstr 3503); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), oral

Somatic DNA mutations, mutational load (ML), and MSI status: association with overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) of CALGB/SWOG 80405 Alliance)

F Innocenti;FS Qu;T Zemla;D Niedzwiecki;X Qu;R Tam;SA Mahajan;R Goldberg;RJ Mayer;M Bertagnolli;H Hochster;C Blanke;A Venook;H Lenz;O Kabbarah J Clin Oncol 35, 2017 (suppl; abstr 3504); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), oral

Impact of consensus molecular subtyping (CMS) on overall survival (OS) and progression free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB / SWOG 80405 (Alliance)

H Lenz;FS Ou;A Venook;H Hochster;D Niedzwiecki;R Goldberg;R Mayer;M Bertagnolli;C Blanke;T Zemla;X Qu;O Kabbarah;F Innocenti J Clin Oncol 35, 2017 (suppl; abstr 3511); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), oral presentation

Prognostic and predictive value of primary tumour side in patients with RAS wild-type metastatic colorectal cancer treated with chemotherapy and EGFR directed antibodies in six randomized trials

D Arnold;B Lueza;JY Douillard;M Peeters;H-J Lenz;A Venook;V Heinemann;E Van Cutsem;J Pignon;J Tabernero;A Cervantes;F Ciadiello Annals of Oncology Aug 1;28(8):1713-1729

PMid: PMID28407110 | PMC number: PMC6246616

2016

Variants associated with high grade bevacizumab-induced hypertension identified by exome sequencing: CALGB 80405 (Alliance).

M Li;F Mulkey;C Jiang;B O'Neil;D Niedzwiecki;P Friedman;H Hochster;H Lenz;A Venook;K Owzar;D Kroetz American Society for Clinical Pharmacology and Therapeutics (March 8-12, San Diego, CA), late breaking poster session abst. #LB-041, p. 164

Impact of primary (1º) tumor location on overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB / SWOG 80405

A Venook;D Niedzwiecki;F Innocenti;M Fruth;C Greene;B O'Neil;JE Shaw;B Polite;H Hochster;C Blanke;R Goldberg;R Schilsky;R Mayer;M Bertagnolli;H Lenz Journal of Clinical Oncology 34, 2016 (suppl; abstr 3504); oral American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL),

Blood-Based Biomarkers in Patients (pts) with Metastatic Colorectal Cancer (mCRC) Treated with FOLFOX or FOLFIRI + Bevacizumab (Bev), Cetuximab (Cetux), or Bev + Cetux: Results from CALGB 80405 (Alliance)

AB Nixon;AB Sibley;AJ Hatch;Y Liu;C Jiang;F Mulkey;MD Starr;JC Brady;D Niedzwiecki;F Innocenti;A Venook;H Hochster;H Lenz;B O'Neil;K Owzar;H Hurwitz Journal of Clinical Oncology 34, 2016 (suppl; abstr 3597); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), poster session

2015

Cost of chemotherapy for metastatic colorectal cancer with either bevacizumab or cetuximab: economic analysis of CALGB/SWOG 80405

D Schrag;A Dueck;M Naughton;D Niedzwiecki;C Earle;J Shaw;A Grothey;H Hochster;C Blanke;A Venook Journal of Clinical Oncology 33:5s (suppl; abstr 6504); American Society of Clinical Oncology Annual Meeting (May 29-June 2,2015, Chicago, IL), oral;

Vitamin D status and survival of metastatic colorectal cancer patients: Results from CALGB/SWOG 80405 (Alliance)

K Ng;AP Venook;K Sato;BW Hollis;D Niedzwiecki;C Ye;I-W Chang;BH O'Neil;F Innocenti;H-J Lenz;CD Blanke;CS Fuchs;JA Meyerhardt Journal of Clinical Oncology 33(suppl 3; abstr 507); poster; ASCO Gastrointestinal Cancers Sympos (Jan 15-17, 2015, San Francisco, CA);

Outcomes for FOLFIRI plus bevacizumab (BEV) or cetuximab (CET) in patients previously treated with oxaliplatin-based adjuvant therapy: A combined analysis of data from FIRE-3 and CALGB 80405

V Heinemann;D Niedzwiecki;R Pearline;H Lenz;F Innocenti;H Hochster;A Grothey;RM Goldberg;RJ Mayer;RL Schilsky;M Bertagnolli;C Blanke;A Venook;S Stinzing;BH O'Neil Journal of Clinical Oncology 33:5s (suppl; abstr 3585); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster session;

Vitamin D status and survival of metastatic colorectal cancer patients: Results from CALGB/SWOG 80405 (Alliance)

K Ng;A Venook;K Sato;K Holllis;D Niedzwiecki;C Ye;I Chang;BH O'Neil;F Innocenti;H Lenz;C Blanke;RJ Mayer;C Fuchs;JA Meyerhardt Journal of Clinical Oncology 33:5s (suppl; abstr 3503); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), oral presentation;

A genome-wide association study (GWAS) of overall survival (OS) in 609 metastatic colorectal cancer (mCRC) patients treated with chemotherapy and biologics in CALGB 80405

F Innocenti;K Owzar;C Jiang;A Sibley;D Niedzwiecki;M Bertagnolli;PN Friedman;Y Furukawa;M Kubo;M Ratain;CD Blanke;H-J Lenz;A Venook;H McLeod Journal of Clinical Oncology 33:5s (suppl; abstr 3599); American Society of Clinical Oncology Annual Meeting, poster session;

A genome-wide association study (GWAS) of overall survival (OS) in 609 metastatic colorectal cancer (mCRC) patients treated with chemotherapy and biologics in CALGB 80405

F Innocenti;K Owzar;C Jiang;AB Sibley;D Niedzwiecki;M Bertagnolli;P Friedman;Y Furukawa;M Kubo;M Ratain;CD Blanke;H Lenz;A Venook;H McLeod European Cancer Congress (ESMO) Annual Meeting, (Sept 25-29 2015, Vienna, Austria) oral presentation, abst. 2007;

2014

CALGB/SWOG 80405: PHASE III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (uMCRC).

AP Venook;D Niedzwiecki;H-J Lenz;F Innocenti;MR Mahoney;BH O'Neil;JE Shaw;BN Polite;H Hochster;JN Atkins;RM Goldberg;RJ Mayer;RL Schilsky;M Bertagnolli;CD Blanke Journal of Clinical Oncology 32:5s (suppl; abstr LBA3); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), scientific plenary session (oral);

CALGB/SWOG C80405: PHASE III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with expanded ras analyses untreated metastatic adenocarcinoma of the colon or rectum (MCRC)

H Lenz;D Niedzwiecki;F Innocenti;C Blanke;MR Mahoney;BH O'Neil;JE Shaw;B Polite;H Hochster;J Atkins;RM Goldberg;RJ Mayer;RL Schilsky;M Bertagnolli;A Venook Annals of Oncology 25 (Suppl 4): iv1 - mdu438.66; ESMO 2014 Congress (Sept 26-30, 2014, Madrid, Spain), oral presentation;

2013

Comparison of dietary and lifestyle habits among stage III and metastatic colorectal cancer patients: findings from CALGB 89803 and CALGB 80405

K Van Loon;D Wigler;D Niedzwiecki;AP Venook;C Fuchs;C Blanke;L Saltz;RM Goldberg;JA Meyerhardt Clinical Colorectal Cancer 12(2):95-102;

PMid: PMID23317558 | PMC number: PMC3790266

2007

Revisiting the Cancer and Leukemia Group B/Southwest Oncology Group 80405 trial: a phase II trial of chemotherapy and biologic agents for patients with untreated advanced colorectal adenocarinoma

AP Venook;CD Blanke;D Niedzwiecki;HJ Lenz;JR Taylor;DR Hollis;S Sutherland;RM Goldberg Clinical Colorectal Cancer 6(7):536-538

PMid: PMID17553204

2005

Cancer and Leukemia Group B/Southwest Oncology Group trial 80405: a phase III trial of chemotherapy and biologics for patients with untreated advanced colorectal adenocarcinoma PMID16356309

A Venook;C Blanke;D Niedzwiecki;HJ Lenz;J Taylor;D Hollis;S Sutherland;R Goldberg Clinical Colorectal Cancer 5(4):292-294

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