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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

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ClinicalTrials.gov Identifier: NCT00022139
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE August 10, 2001
First Posted Date  ICMJE March 7, 2003
Last Update Posted Date December 7, 2016
Study Start Date  ICMJE January 2002
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Proportion of successes [ Time Frame: Up to 4 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • Toxicity-free rate [ Time Frame: Up to 4 years ]
  • Clinical tumor response [ Time Frame: Up to 4 years ]
  • Pathologic tumor response [ Time Frame: Up to 4 years ]
  • Time to disease progression [ Time Frame: Up to 4 years ]
  • Surgical outcome [ Time Frame: Up to 4 years ]
  • Survival [ Time Frame: Up to 4 years ]
  • Time to treatment failure [ Time Frame: Up to 4 years ]
  • Quality of life [ Time Frame: Up to 4 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Official Title  ICMJE A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Gastric Cancer
Intervention  ICMJE
  • Drug: carboplatin
  • Drug: fluorouracil
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Study Arms  ICMJE Experimental: carboplatin + paclitaxel + fluorouracil + radiation + surgery

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.

Interventions:
  • Drug: carboplatin
  • Drug: fluorouracil
  • Drug: paclitaxel
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
56
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00022139
Other Study ID Numbers  ICMJE NCCTG-N0044
NCI-2012-02394 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000068789 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Aminah Jatoi, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date December 2016

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