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Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer Clinical research trials and Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer. Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer clinical trial. Subjects frequently get the best healthcare possible for their Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer  Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
For Condition: squamous cell carcinoma of the esophagus,stage 3 esophageal cancer,Adenocarcinoma of the Esophagus,stage 2 esophageal cancer
Status: Recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as docetaxel 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. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: Phase II trial to study the effectiveness of neoadjuvant docetaxel combined with cisplatin plus chemoradiotherapy followed by surgery in treating patients who have locally advanced, resectableesophageal cancer.
Details: OBJECTIVES: Primary - Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer. - Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients. Secondary - Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results. - Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. - Determine the clinical benefit of this regimen in these patients. OUTLINE: This is a multicenter study. - Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22. - Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks. - Surgery: Patients undergo surgery 3-8 weeks after the final administration of radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) - Locally advanced disease that is technically operable with curative intent (R0) - T3, N0 OR T1-3, N+ OR T4, NX - No T1-2, N0 - No inoperable T4 (unequivocal organ involvement) - No distant metastasis, including M1a lymph node status - Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology - No carcinoma of the cervical esophagus - Obstructive tumors allowed PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - Bilirubin no greater than 1.5 times ULN Renal - Creatinine clearance greater than 60 mL/min Cardiovascular - No New York Heart Association class III or IV congestive heart failure - No unstable angina pectoris - No myocardial infarction within the past 3 months - No significant arrhythmias - No other severe or uncontrolled cardiovascular disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 12 months after study treatment - No definite contraindications to corticosteroids as premedication - No geographic situation that would preclude proper staging and follow-up - No active uncontrolled infection - No preexisting peripheral neuropathy greater than grade 1 - No uncontrolled diabetes mellitus - No active autoimmune disease - No other serious medical condition that would preclude study participation - No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix - No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the chest Surgery - Not specified Other - More than 30 days since prior treatment on another clinical trial - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasRuhstaller, Study Chair, Kantonsspital - St. Gallen
Ratisches Kantons und Regionalspital *Recruiting*
Chur, , CH-7000
Switzerland
Recruiting Fritz Egli 41-81-256-6645
Kantonspital Aarau *Recruiting*
AARAU, , 5001
Switzerland
Recruiting Walter Mingrone 41-62-838-6050
City Hospital Triemli *Recruiting*
Zurich, , 8063
Switzerland
Recruiting Lucas Widmer 41-1-466-1111
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Razvan Popescu 41-21-314-0165
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Markus Borner 41-31-632-4114
Kantonsspital - St. Gallen *Recruiting*
St. Gallen, , CH-9007
Switzerland
Recruiting Dieter Koeberle 41-71-494-1111
Istituto Oncologico della Svizzera Italiana *Recruiting*
Lugano, , CH-6900
Switzerland
Recruiting Piercarlo Saletti 41-91-811-6772
Hopital Cantonal Universitaire de Geneve *Recruiting*
Geneva, , CH-1211
Switzerland
Recruiting Arnaud Roth 41-22-372-7744
Universitatsklinken Basel *Recruiting*
Basel, , CH-4031
Switzerland
Recruiting Richard Herrmann 41-61-265-5075
Additional Information:
Study ID Numbers: CDR0000335172; EU-20323,SWS-SAKK-75/02
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072033
Other Stage 3 Esophageal Cancer Studies:
1. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
2. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
3. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
5. DX-8951f in Treating Patients With Metastatic Stomach Cancer
Related Studies:
Other stage 3 esophageal cancer Clinical Trials
Other Clinical Trials
Other Zurich Clinical Trials
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
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