Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT00160875
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In patients who have a very good response to this treatment, survival following esophagectomy has increased, although the amount of increase has varied quite a bit between the different studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this combination of drugs has been beneficial, we wish to use a newer combination of drugs which may be more effective for esophageal cancer. The chemotherapy drugs used in this study are Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when given with radiation, and how often these side effects occur.

Key Dates

Start date
Apr 30, 2009
Status verified
May 2017
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cisplatin, Irinotecan

Primary Outcome Measure

pathological complete response [ Time Frame: 1 day ]

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