Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00021320|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 9, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: cisplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 2|
- Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and fluorouracil with concurrent radiotherapy.
- Determine the complete and partial responses in patients treated with this regimen.
- Assess the toxicity of this regimen in these patients.
- Determine the optimal dose of paclitaxel when administered in this regimen in these patients.
- Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses.
Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks.
At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy.
Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Official Title:||Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||April 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021320
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Study Chair:||Jonathan Cheng, MD||Fox Chase Cancer Center|