Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006472
First received: November 6, 2000
Last updated: February 6, 2009
Last verified: February 2002
  Purpose

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. Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I, stage II, or stage III esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Drug: carboplatin
Drug: fluorouracil
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Esophageal Cancer: A Phase II Study of Paclitaxel, Carboplatin and 5-Fluorouracil With Simultaneous Radiotherapy Followed by Surgical Resection

Resource links provided by NLM:


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

Study Start Date: January 2000
Detailed Description:

OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent radiotherapy followed by surgical resection. II. Determine the overall survival of these patients treated with this regimen. II. Determine the toxicity of this regimen in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then undergo surgical resection within 3-5 weeks following completion of therapy. Patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the upper, middle, or lower third esophagus Stage I, II, or III disease Measurable disease No distant metastases Negative liver biopsy Negative bone scan unless due to benign disease No tracheobronchial involvement No vocal cord paralysis No phrenic nerve involvement No celiac axis lymph node involvement unless due to primary cancer at gastroesophageal junction No evidence of disseminated cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled or severe cardiovascular disease No congestive heart failure No myocardial infarction within the past 6 months No severe or uncontrolled hypertension (systolic greater than 150 mmHg and diastolic greater than 100 mmHg) Pulmonary: FEV1/FVC at least 75% predicted Arterial blood saturation at least 92% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No other serious medical illness that would limit survival to fewer than 2 years No active uncontrolled bacterial, viral, or fungal infection No active uncontrolled duodenal ulcer No psychiatric disorder that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior chest radiotherapy Surgery: No prior surgical resection of tumor Other: No prior therapy for esophageal cancer

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006472

Locations
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Good Samaritan Hospital of Maryland
Baltimore, Maryland, United States, 21239
Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
Washington Hospital Center
Investigators
Study Chair: David J. Perry, MD Washington Hospital Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006472     History of Changes
Other Study ID Numbers: CDR0000068295, WHC-99692, NCI-V00-1633
Study First Received: November 6, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Carboplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014