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Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Clinical research trials and Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction. Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction clinical trial. Test subjects typically obtain the finest healthcare available for their Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction  Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
For Condition: squamous cell carcinoma of the esophagus,stage 3 esophageal cancer,stage 2 esophageal cancer,Adenocarcinoma of the Esophagus
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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. Combining chemotherapy with radiation therapy may kill more tumor cells PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy, with or without surgery, in treating patients who have resectablelocally advanced cancer of the esophagus or gastroesophageal junction.
Details: OBJECTIVES: - Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction. - Determine the overall and disease-free survival of patients treated with this regimen. - Determine the treatment-related toxicity of this regimen in these patients. - Determine the tolerance to surgical salvage in patients treated with this regimen. - Determine the morbidity and mortality of surgical salvage in patients treated with this regimen. OUTLINE: This is a multicenter study. - Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity. - Chemoradiotherapy: Beginning approximately 1 month after completion of induction therapy, patients receive cisplatin IV over 1 hour on days 1-5. Patients also receive 5-FU IV continuously over 24 hours 5 days a week for 6 weeks. Patients concurrently undergo external beam radiotherapy 5 days a week for 6 weeks. Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy. Patients are followed at 3 and 6 months, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction - Primary (non-recurrent) disease - Amenable to resection - Stage greater than T1, N0 by endoscopic ultrasound - Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue - Tumor may not extend more than 2 cm into the stomach - No multiple primary carcinomas of the esophagus - No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus - No evidence of disseminated cancer - Suggestion of liver metastases on imaging studies must be proven negative by biopsy - Palpable supraclavicular nodes must be negative for cancer by biopsy - Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion - No celiac adenopathy greater than 2 cm PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Not specified Renal - Creatinine no greater than 1.5 mg/dL AND/OR - Creatinine clearance at least 65 mL/min - Calcium no greater than 11 mg/dL Cardiovascular - No heart disease - No hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to comprehend study requirements and considered likely to comply with study parameters - No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix - No uncontrolled diabetes - No hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior systemic chemotherapy for this or any other malignancy (unless disease free for more than 5 years) Endocrine therapy - Not specified Radiotherapy - No prior chest or upper abdomen radiotherapy Surgery - No prior esophageal or gastric surgery Other - No concurrent photodynamic therapy - No other concurrent investigational agents for esophageal carcinoma
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenSwisher, Study Chair, Radiation Therapy Oncology Group
Regional Radiation Oncology Center at Rome *Recruiting*
Rome, Georgia, 30165
United States
Recruiting M.P. Mumber 706-234-1400
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Additional Information:
Study ID Numbers: CDR0000306455; RTOG-0246
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069953
Other Adenocarcinoma Of The Esophagus Studies:
1. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
2. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
3. Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
4. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach
5. Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
Related Studies:
Other Adenocarcinoma of the Esophagus Clinical Trials
Other Georgia Clinical Trials
Other Rome Clinical Trials
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
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