Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma

• Sponsor: University of Michigan Rogel Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00230451
• Collaborator: (none)
• Location: 1
• Duration (Months): 128

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: Radiation; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-Fluorouracil	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Nov 1, 1997
• Actual Primary Completion Date: Dec 1, 1999
• Actual Study Completion Date: Jul 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Cancer Center	Ann Arbor	Michigan	United States	48197

Sponsors and Collaborators

• University of Michigan Rogel Cancer Center

Investigators

• Principal Investigator: Susan Urba, M.D., University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00230451
• Other Study ID Numbers: UMCC 9740
• First Posted: Sep 30, 2005
• Last Update Posted: Jan 15, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Esophageal Neoplasms; Paclitaxel; Fluorouracil

Study Results

No Results Posted as of Jan 15, 2010