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Principal Name   Harvey Zimbler, MD
Contact Name   Gloria Gero
Phone   (413) 496-8205
Alternate Phone   (413) 443-6000
Fax   (413) 443-2203
Title   N1048: " A Phase II/III Trial of Neoadjuvant FOLFOX with Sellective Use of Combined Modality Chemoradiation vs Preop Combined Modality Chemoradiation for Locally Adv Rectal Cancer Patients Undergoing Low Ant Resection with Total Mesorectal Excisio
Description   This Phase II/III seeks to determine whether 6 cycles of neoadjuvant FOLFOX followed by comprehensive restaging with selective use of 5FUCMT followed by total mesorectal excision (TME) achieves favorable outcomes for patients with locally advanced rectal cancer. The current standard of care for locally advanced rectal cancer involves use of 5FUCMT for all patients. In the interventions group, 5FUCMT is used selectiviely and is administered to the subset of patients randomized to the intervention group who are either:
1) unable to complete 6 cycles of FOLFOX
2) have evidence of progression after 6 cycles of FOLOFOX
3) fail to undergo ana pelvic R0 resection
4) withdraw consent from the study

This study has potential to dramatically influence our approach to rectal cancer treatment.
Treatment   Oncology
Inclusion/Notes   Inclusion:
-18 years of age
-diagnosis of rectal adenocarcinoma
-radiologically measurable or clinically evaluable disease
-ECOG performance Status (PS): 0,1 or 2
-Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
-Primary surgeon is credentialed or is willing to be credeneitaled in TME by Alliance SUrgery Committee.
-Clinical stage: T2N1, T3N0, T3N1
-preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from anal verge

Exlusion:
-Clinical T4 tumors
-Evidence that tumor is adjacent to the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan
-tumor is causing symptomatic bowel obstruction
-any prior pelvic radiation
Status   accruing
Start Date   10/03/2012
Current Trial Type   treatment


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