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OpenTrials
Completed

NCT Number: NCT00230451

Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48197, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Eligibility:

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

Exclusion criteria

  • 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.
  • No prior treatment allowed. No prior thoracic radiation.

Treatment and study plan

Radiation

Procedure

paclitaxel

Drug

Cisplatin

Drug

5-fluorouracil

Drug

Primary outcomes

  1. To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.

Secondary outcomes

  1. To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.

  2. To assess the qualitative and quantitative toxicities of this regimen.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

A Phase II Trial of Preoperative Chemotherapy and Radiation Therapy Followed by Adjuvant Combination Chemotherapy for Patients With Loco-Regional Esophageal Carcinoma

Important dates

Study start
1997
Primary completion
1999
Study completion
2008
First posted
Sep 30, 2005
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.