Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

This study has been completed.
Sponsor:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00230451
First received: September 28, 2005
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

Surgery (esophagectomy or removal of the esophagus)has been the standard treatment for cancer of the esophagus. However, evidence suggests that preoperative chemotherapy and radiation therapy may add benefit. The purpose of this study is to determine if a treatment program of combined chemotherapy and radiation therapy prior to surgery and chemotherapy after surgery will delay or eliminate recurrence of the cancer.


Condition Intervention Phase
Esophageal Cancer
Procedure: Radiation
Drug: Paclitaxel
Drug: Cisplatin
Drug: 5-Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.

Secondary Outcome Measures:
  • To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
  • To assess the qualitative and quantitative toxicities of this regimen.

Study Start Date: November 1997
Study Completion Date: July 2008
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patient Eligibility:

  1. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or mixed adeno/squamous of the the esophagus or gastroesophageal junction.
  2. Disease limited to the esophagus and regional lymph nodes. However, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
  3. Disease must be able to be encompassed in a single radiation field.
  4. No medical contraindication to surgery.
  5. All treatment is to be administered at the University of Michigan Medical Center
  6. Karnofsky Performance Status > 60%
  7. Ages 18-75
  8. Adequate renal function (BUN <1.5 x N; creatinine <1,5 mg/dl, or measured creatinine clearance>60 ml/min.).
  9. Adequate bone marrow reserve (WBC>3500/ul; Platelets>100,000/ul.).
  10. Adequate hepatic function (Bilirubin<1.5x N; AST <2 x upper limit of normal).
  11. Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5 year disease-free period.
  12. Ability to give informed consent.

Exclusion Criteria:

  1. Patients with active infection, pregnancy, lactating females, serious inter-current medical conditions including congestive heart failure, cardiac arrhythmias, or symptomatic coronary artery diseases are ineligible.
  2. No prior treatment allowed. No prior thoracic radiation.
  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: NCT00230451

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Susan Urba, M.D. University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: Susan G. Urba, M.D., University of Michigan
ClinicalTrials.gov Identifier: NCT00230451     History of Changes
Other Study ID Numbers: UMCC 9740
Study First Received: September 28, 2005
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014