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Clinical Trials

Topic   Rectal Cancer
Title   N1048: A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total...
Summary   Full Title: N1048: A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)

The main objective of this study is to determine whether the usual approach (also known as the standard of care) is better, worse or the same as the proposed approach. All of the drugs are FDA approved and have been routinely used in treating advanced colorectal cancer since 2002. When surgery and treatment are finished the study doctor will evaluate patients for up to five years after randomization and keep track of patient’s medical condition for up to eight years after randomization.
Description   Patients on this study will be split into two groups; one receiving the standard of care treatment for advanced colorectal cancer prior to surgery and the other with receive FOLFOX chemotherapy with no radiation prior to surgery.
IRB Number   17028
Inclusion/Notes   To be eligible for this study patients must meet several criteria, including but not limited to the following: patients must be 18 years of age or older, diagnosed with clinical Stage II or III rectal adenocarcinoma and be a candidate for surgery.
Status   Open
Start Date   01/13/2012
Principal Name   Prashanti Atluri, MD
Contact Name   Susan Romano, RN
Email   Susan.Roman@nyulangone.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1081
Alternate Phone   516-663-3115