Finding studies
Finding studies
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Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary \* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer. Secondary * Determine the activity, in terms of clinical response rate and adverse event profile of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy. * Determine the overall survival, time-to-progression, and time-to-treatment failure for patients receiving the above combined modality treatment. * Determine the surgical outcome for all patients who undergo esophagectomy. * Determine the time-to-disease recurrence and disease-free survival for patients who have a curative resection. * Determine quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5 ½ weeks and concurrently receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on days 1 and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are eligible will undergo esophagectomy between 4-12 weeks after completion of radiotherapy. Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and within 2 weeks prior to surgery. After completion of study treatment, patients are followed periodically for approximately 4 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted