Status:
COMPLETED
Trimodality Management of T1b Esophageal Cancers
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving chemotherapy and radiation therapy before surgery for early-stage esophageal cancer can help to control the disease and if so, for how lo...
Detailed Description
The Study Treatment: 5-fluorouracil and docetaxel are designed to stop the growth of cancer cells, which may cause the cells to die. Docetaxel may also damage blood vessels in tumor tissue. The radi...
Eligibility Criteria
Inclusion
- Histologically documented adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction that are staged as T1b using endoscopic ultrasound (EUS) or from a large biopsy (either criteria # 1 or #2 can be met for eligibility).
- Patients who undergo a diagnostic Endoscopic Mucosal Resection (EMR) and have a diagnosis of T1b stage established.
- Performance score Karnofsky Performance Scale (KPS) 80-100.
- Patients should be surgical candidates for esophagectomy and should have no contraindications for chemotherapy or radiation.
- Negative pregnancy test for women of child bearing potential. They must agree to adequate contraception.
- Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, ALT (SGPT), AST (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) \>2,500/uL, platelets \> 75,000/uL), renal (creatinine clearance \> 50 mL/min), and liver function (bilirubin \<=1.5 fold the upper limit of normal and liver enzymes \< 3 fold the upper limit of normal).
- Based on the risk factors and propensity of lymph node metastasis (LNM) and poorer survivals seen in retrospective studies as discussed in the introduction, only patients with any one (1) of high risk features such as LVI, tumors \>1.2 cm, and high grade will be enrolled (Grade is the pathologic term defining the degree of differentiation. Grade 1 is well differentiated, Grade 2 is moderately differentiated, and Grade 3 is poorly differentiated).
Exclusion
- Prior radiation to the chest
- Previous or concomitant cancers other than 1) curatively treated carcinoma in situ of cervix, basal cell of the skin, curative treatment for transitional cell carcinoma of the bladder, and early stage cancers at another non-overlapping site that was treated more than 3 years ago for cure.
- Pregnant or breast-feeding females
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device c) no myocardial infarction within 3 months of registration
- Known hypersensitivity to docetaxel, 5-fluorouracil, polysorbate-80, or any component of the formulation
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01217060
Start Date
October 1 2010
End Date
June 14 2020
Last Update
April 13 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030