Spots Global Cancer Trial Database for Neo-adjuvant Chemoradiotherapy Using Infusional Gemcitabine Followed by Surgery for Locally Advanced Rectal Cancer

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Trial Identification

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

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

Study ID: NCT02919878

Conditions

Rectal Adenocarcinoma

Interventions

Gemcitabine

XRT

capecitabine

Study Description

Brief 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.

Detailed 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 %.