SWOG clinical trial number
S0713

A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-operative Therapy of Rectal Cancer

Closed
Phase
II
Accrual
94%
Published
Abbreviated Title
Ph II Rectal Pre-Operative ChemoRT
Activated
02/01/2009
Closed
04/15/2013
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists, Surgeons, Affiliates

Research committees

Gastrointestinal Cancer

Treatment

Oxaliplatin Capecitabine Cetuximab

Eligibility Criteria Expand/Collapse

Stage II-III biopsy-proven non-recurrent primary adenocarcinoma of the rectum. Distal border of tumor at or below peritoneal reflection. Patient must have wild-type k-ras (testing may be performed either by a CLIA-certified local lab or by the study's central lab). Measurable and/or non-measurable disease. No prior chemo, RT, or targeted tx for this tumor. No investigational agents within 28 days prior to reg. No prior severe reaction to monoclonal antibody. Must have recovered from any recent major surgeries. Must be willing to submit additional specimens. Zubrod 0-2. No peripheral neuropathy >/= Grade 2. No uncontrolled coagulopathy. No high-grade obstruction. No history of allergy to platinum compounds or to antiemetics. No prior unanticipated severe reaction to fluoropyrimidine tx, known sensitivity to 5-FU, or known DPD deficiency. No inflammatory bowel disease, malabsorption syndrome or inability to swallow that would impair the ingestion or absorption of capecitabine. No uncontrolled intercurrent illness. No ongoing or active infection, symptomatic CHF, or unstable angina pectoris. No cardiac arrhythmia or MI within the last 12 months. Must not be receiving anti-retroviral tx for HIV. Within 28 days prior to reg: assessment of measurable disease; leukocytes >/= 3,000/mcl; granulocytes >/= 1,500/mcl; platelets >/= 100,000/mcl; bilirubin </= 1.5 x IULN; alkaline phosphatase </= 2.5 x IULN; SGOT or SGPT </= 2.5 x IULN; calculated creatinine clearance > 50 mL/min. Within 42 days prior to reg: assessment of non-measurable disease.

Publication Information Expand/Collapse

2018

SWOG S0713: A phase II study of cetuximab added to induction chemotherapy of oxaliplatin and capecitabine, followed by neoadjuvant chemoradiation for locally advanced rectal cancer

C Leichman;S McDonough;S Smalley;K Billingsley;H Lenz;M Beldner;A Hezel;M Velasco;K Guthrie;C Blanke;H Hochster Clinical Colorectal Cancer Mar;17(1):e121-e125; 2017 Oct 24 [Epub ahead of print]

PMid: PMID29233486

2015

SWOG S0713: A phase II study of cetuximab (CET) added to induction chemotherapy (ICT) of oxaliplatin (OX), capecitabine (CAP), followed by neoadjuvant chemoradiation (NACR) for locally advanced rectal cancer (LARC)

CG Leichman;S McDonough;S Smalley;K Billingsley;H Lenz;A Hezel;M Velasco;M Beldner;K Guthrie;C Blanke;H Hochster Journal of Clinical Oncology 33:5s (suppl;abstr 3516); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster discussion;

2014

Consequences of anorectal cancer atlas implementation in the cooperative group setting: radiobiologic analysis of a prospective randomized in silico target delineation study

P Mavroidis;D Giantsoudis;M Awan;CRN Rasch;JC Duppen;CR Thomas;P Okunieff;WE Jones;L Kachnic;N Papanikolaou;CD Fuller Radiotherapy and Oncology 112(3):418-424;

PMid: PMID24996454 | PMC number: PMC4258107

2012

Target delineation in rectal cancer radiotherapy radiobiological consequences of atlas implementation

P Mavroidis;CD Fuller;D Giantsoudis;J Nijkamp Duppen;CRN Rasch;CR Thomas;P Okunieff;WE Jones III;LA Kachnic;N Papanikolaou ESTRO 31 (May 9-12, 2012, Barcelona, Spain), poster, abst. PO-0782;

2011

Prospective randomized double-blind pilot study of site-specific consensus atlas implementation for rectal cancer target volume delineation in the cooperative group setting [PMID20400244; PMC2929319]

CD Fuller;J Nijkamp;CR Rasch;CR Thomas, Jr;SJ Wang;P Okunieff;WE Jones;D Baseman;S Patel;CG Demandante;AM Harris;BD Smith;AW Katz;C McGann;JL Harper;DT Chang;S Smalley;DT Marshall;KA Goodman;N Papanikkolaou;LA Kachnic International Journal of Radiation Oncology, Biology & Physics 79(2):481-489

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Research Committee(s)
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Research Committee(s)
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Activated
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Phase
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