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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

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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: carboplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer
Study Start Date : January 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : January 2009


Arm Intervention/treatment
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.

Drug: carboplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy



Primary Outcome Measures :
  1. Proportion of successes [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Toxicity-free rate [ Time Frame: Up to 4 years ]
  2. Clinical tumor response [ Time Frame: Up to 4 years ]
  3. Pathologic tumor response [ Time Frame: Up to 4 years ]
  4. Time to disease progression [ Time Frame: Up to 4 years ]
  5. Surgical outcome [ Time Frame: Up to 4 years ]
  6. Survival [ Time Frame: Up to 4 years ]
  7. Time to treatment failure [ Time Frame: Up to 4 years ]
  8. Quality of life [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00022139


Locations
Show Show 35 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Aminah Jatoi, MD Mayo Clinic
Publications of Results:
Other Publications:
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00022139    
Other Study ID Numbers: NCCTG-N0044
NCI-2012-02394 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000068789 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
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
Additional relevant MeSH terms:
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Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Paclitaxel
Carboplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs