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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
For Condition: stage 3 esophageal cancer,stage 0 esophageal cancer,stage 2 esophageal cancer,stage 1 esophageal cancer,squamous cell carcinoma of the esophagus,Adenocarcinoma of the Esophagus
Status: No longer recruiting
Sponsor(s): Fox Chase Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.
Details: OBJECTIVES: - Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and fluorouracil with concurrent radiotherapy. - Determine the complete and partial responses in patients treated with this regimen. - Assess the toxicity of this regimen in these patients. - Determine the optimal dose of paclitaxel when administered in this regimen in these patients. - Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses. Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks. At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy. Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction - Potentially resectable disease - No malignant celiac node involvement - No cervical esophageal carcinoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,800/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No significant medical or psychiatric illness that would preclude study - Not pregnant or nursing - Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for esophageal cancer Endocrine therapy: - Not specified Radiotherapy: - No prior thoracic radiotherapy Surgery: - See Disease Characteristics - No prior surgical resection of esophageal tumor
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanCheng, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
United States
Additional Information:
Study ID Numbers: CDR0000068769; FCCC-00003,NCI-G01-1982
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021320
Other Stage 3 Esophageal Cancer Studies:
1. Combination Chemotherapy Combined with Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
2. Positron Emission Tomography in Determining Stage of Esophageal Cancer
3. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
4. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
5. Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Related Studies:
Other stage 3 esophageal cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
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