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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
For Condition: stage 2 esophageal cancer,Adenocarcinoma of the Esophagus,squamous cell carcinoma of the esophagus,stage 3 esophageal cancer
Status: Recruiting
Sponsor(s): Norris Cotton 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. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.
Details: OBJECTIVES: - Determine the maximum tolerated dose of capecitabine when administered with docetaxel and concurrent external beam radiotherapy following neoadjuvant docetaxel and carboplatin in patients with stage II or III carcinoma of the esophagus or gastroesophageal junction. - Determine the clinical and pathological response rate, rate of resectability, duration of response, patterns of failure, and survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of capecitabine. Patients receive neoadjuvant docetaxel IV over 1 hour on day 1 of weeks 1 and 4 and carboplatin IV over 30 minutes on day 2 of week 1 and day 1 of week 4. Beginning at week 7, patients undergo external beam radiotherapy once daily 5 days a week for 28 days. Patients also receive concurrent docetaxel IV over 15-30 minutes once weekly for 5 weeks and oral capecitabine once daily for 28 days. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity. Patients are followed at week 15, at least every 6-9 weeks for 6 months, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 8-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction - Locally advanced and surgically resectable stage II or III disease (T2-4, N0, M0 or T1-4, N1, M0) - Bulk of tumor must involve the esophagus or gastroesophageal junction if tumor extends below the gastroesophageal junction into the proximal stomach - No clinical evidence of metastasis to cervical or supraclavicular lymph nodes - Celiac axis lymph node metastases in gastroesophageal junction cancer allowed - No cervical esophageal tumor - No recurrent laryngeal nerve or phrenic nerve paralysis - No gastric cancer with only minor involvement of the gastroesophageal junction or distal esophagus - No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula - No brain, bone, pulmonary, or liver metastases - No positive pleural, pericardial, or peritoneal cytology PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST or ALT no greater than 5 times ULN - Alkaline phosphatase no greater than 5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 50 mL/min - Calcium no greater than 12 mg/dL Other: - No grade 2 or greater peripheral or auditory neuropathy - No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix - No serious infection or nonmalignant medical illness - No psychiatric disorder that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior chest or abdominal radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesRigas, Study Chair, Norris Cotton Cancer Center
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting James Rigas 603-650-6344
Additional Information:
Study ID Numbers: CDR0000068542; DMS-9939,NCI-G01-1931
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014417
Other Stage 3 Esophageal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
2. Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
3. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
4. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
5. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Related Studies:
Other stage 3 esophageal cancer Clinical Trials
Other New Hampshire Clinical Trials
Other Lebanon Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
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