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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 Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 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 website committed 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 happen in hundreds of localities 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, 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 permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes 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. Participants frequently obtain the most expert 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 can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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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 Stage 2 Esophageal Cancer Studies:
1. Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
2. Positron Emission Tomography in Determining Stage of Esophageal Cancer
3. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
4. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
5. Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
Related Studies:
Other stage 2 esophageal cancer Clinical Trials
Other Arizona Clinical Trials
Other Phoenix 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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