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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
This study has been completed.
Study NCT00021320   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: August 29, 2009   History of Changes

July 11, 2001
August 29, 2009
May 2000
April 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00021320 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer

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.

OBJECTIVES:

  • 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.

Phase II
Interventional
Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
April 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction

    • Potentially resectable disease
  • No malignant celiac node involvement
  • No cervical esophageal carcinoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,800/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No significant medical or psychiatric illness that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for esophageal cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior thoracic radiotherapy

Surgery:

  • See Disease Characteristics
  • No prior surgical resection of esophageal tumor
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00021320
 
CDR0000068769, FCCC-00003, NCI-G01-1982
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Jonathan Cheng, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP