NCT02919878

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 %.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Nucleoside analog- Chemotherapy
RADIATION	XRT	pre-operative radiotherapy given concurrently with Gemcitabine chemotherapy
DRUG	capecitabine	Capecitabine is given post operatively as adjuvant chemotherapy for 6 cycles. Each cycle consist of 2500 mg/m2 per day given orally from D1-14

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-09-29
• Last updated: 2018-08-13

Locations

1 site across 1 country: Saudi Arabia