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Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced Rectal Cancer

Rectal Adenocarcinoma Clinical Trial

Official title:
Phase II Study of Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced (T3 and T4 or Node Positive) Rectal Adenocarcinoma

Clinical Trial Summary

Phase II Study of Neo-adjuvant Chemoradiotherapy using infusional Gemcitabine followed by Surgery for Locally Advanced (T3 and T4 or Node positive) Rectal Adenocarcinoma.

Clinical Trial Description

Results of neo-adjuvant chemo-radiation for advanced rectal cancer have plateaued with pathological complete response rates of 10-20% in spite of the addition of new cytotoxic agents and/ or molecular targeted therapies. The combination of 5-fluorouracil and radiation produces effective sensitization but further improvements require assessment of other sensitizers to increase the pathological complete response rates. Gemcitabine has been used in combination with radiation for several GI cancers but few studies have examined its role in rectal cancer. This study will examine a combination of Gemcitabine and radiation as neo-adjuvant therapy in advanced rectal cancer to increase the pathological complete response (pCR) rate from the investigators traditional 6% to > 40 %. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02919878
Study type Interventional
Source King Faisal Specialist Hospital & Research Center
Contact Shouki Bazarbashi, MD
Phone 00966 11 442 3935
Email bazarbashi@kfshrc.edu.sa
Status Recruiting
Phase Phase 2
Start date December 2014
Completion date December 2019
View Details
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