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

NCT00160875 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Irinotecan hydrochloride trihydrate

Irinotecan (65mg/m2) weeks 1-2, 4-5, 7-8

DRUG

Cisplatin

Cisplatin (30 mg/m2) weeks 1-2, 4-5, 7-8

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Darling E Gail, M.D., FRCSC · University Health Network, Toronto

  • Knox J Jennifer, MD,MSc,FRCPC · University Health Network, Toronto

  • Wong KS Rebecca, MSC, FRCSC · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00160875 on ClinicalTrials.gov