Clinical trial NCT00230451: Pre-operative Chemotherapy and Radiation Therapy for Esophageal Carcinoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To determine the rate of complete histologic response induced by this neoadjuvant chemotherapy and radiation therapy regimen.
Secondary outcomes:
measure: To determine the overall survival and time to relapse in patients treated with preoperative chemotherapy and radiation therapy followed by adjuvant combination chemotherapy.
measure: To assess the qualitative and quantitative toxicities of this regimen.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Susan Urba, M.D.
role: PRINCIPAL_INVESTIGATOR
References: