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Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022139
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: carboplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Stomach Cancer   

Drug Information available for:   Carboplatin    Paclitaxel    Fluorouracil   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of successes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity-free rate [ Designated as safety issue: Yes ]
  • Clinical tumor response [ Designated as safety issue: No ]
  • Pathologic tumor response [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Surgical outcome [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]

Study Start Date:   January 2002

Detailed Description:

OBJECTIVES:

  • Determine the pathologic complete response rate in patients with locally advanced cancer of the esophagus or gastroesophageal junction treated with radiotherapy administered concurrently with paclitaxel, carboplatin, and fluorouracil before esophagectomy.
  • Determine the tolerability of this regimen in these patients.
  • Determine the tumor response rate in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.
  • Assess the relationship between the presence of genetic polymorphisms in these patients and the toxicity of this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery.

Patients are followed every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction

    • Surgically resectable disease (T1-3; NX, N0, or N1; M1a)
    • T4 tumors that are not unequivocally unresectable allowed
    • Celiac lymph node (stations 15-20) involvement allowed
  • Must be considered a potential surgical candidate by a thoracic or general surgeon
  • No supraclavicular lymph node involvement by palpation, biopsy, or radiograph (greater than 1.5 cm)
  • No distant metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

    • Patients with ECOG 2 must be considered good candidates for study by treating oncologists

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/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 times ULN

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Other

  • No uncontrolled infection
  • No other severe underlying disease that would preclude study participation
  • No grade 2 or greater peripheral neuropathy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for esophageal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to anticipated fields of study radiotherapy

Surgery

  • Not specified

Other

  • No concurrent diuretics
  • No concurrent amifostine
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022139

Locations
United States, Kansas
Associates in Womens Health, PA - North Review    
      Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman    
      Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita    
      Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute    
      Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City    
      Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado    
      El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower    
      Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton    
      Newton, Kansas, United States, 67114
Wesley Medical Center    
      Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Pratt    
      Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina    
      Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington    
      Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield    
      Winfield, Kansas, United States, 67156
CCOP - Wichita    
      Wichita, Kansas, United States, 67214
Southwest Medical Center    
      Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center    
      Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Parsons    
      Parsons, Kansas, United States, 67357
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota    
      Saint Louis Park, Minnesota, United States, 55416
Duluth Clinic Cancer Center - Duluth    
      Duluth, Minnesota, United States, 55805-1983
Fairview Ridges Hospital    
      Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital    
      Edina, Minnesota, United States, 55435
Miller - Dwan Medical Center    
      Duluth, Minnesota, United States, 55805
Mercy and Unity Cancer Center at Mercy Hospital    
      Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital    
      Fridley, Minnesota, United States, 55432
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center    
      Robbinsdale, Minnesota, United States, 55422-2900
Minnesota Oncology Hematology, PA - Maplewood    
      Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Woodbury    
      Woodbury, Minnesota, United States, 55125
Park Nicollet Cancer Center    
      St. Louis Park, Minnesota, United States, 55416
Ridgeview Medical Center    
      Waconia, Minnesota, United States, 55387
United Hospital    
      St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital    
      Minneapolis, Minnesota, United States, 55407
United States, South Dakota
Avera Cancer Institute    
      Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC    
      Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center    
      Sioux Falls, South Dakota, United States, 57117-5039

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Aminah Jatoi, MD     Mayo Clinic    
Investigator:     Bradley S. Lair, MD     Medical Oncology and Hematology Associates at John Stoddard Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000068789, NCCTG-N0044
First Received:   August 10, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00022139
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III gastric cancer  
stage II esophageal cancer  
stage III esophageal cancer  
adenocarcinoma of the stomach
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Stomach cancer
Carboplatin
Carcinoma
Epidermoid carcinoma
Digestive System Diseases
Stomach Diseases
Paclitaxel
Fluorouracil
Stomach Neoplasms
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 20, 2008




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