drugset / Trial / NCT00258323

Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer

NCT00258323 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.

Timeline

Start
2005-10
Primary completion
2007-07
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Gefitinib Small molecule 250 mg Oral
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous

Indications