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Tracking Information | |||||||||
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First Received Date ICMJE | October 12, 2005 | ||||||||
Last Updated Date | June 4, 2012 | ||||||||
Start Date ICMJE | March 2004 | ||||||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Proportion of patients without local failure measured 6 months after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE |
Proportion of patients without local failure measured 6 months after completion of study treatment | ||||||||
Change History | Complete list of historical versions of study NCT00238407 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery | ||||||||
Official Title ICMJE | Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3 months for 1 year after completion of study treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Esophageal Cancer | ||||||||
Intervention ICMJE |
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Study Arms | Active Comparator: Arm I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Interventions:
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Publications * | Ruhstaller T, Templeton A, Ribi K, Schuller JC, Borner M, Thierstein S, von Moos R, Pederiva S, Lohri A, Lombriser N, von Briel C, Koeberle D, Popescu R. Intense therapy in patients with locally advanced esophageal cancer beyond hope for surgical cure: a prospective, multicenter phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 76/02). Onkologie. 2010;33(5):222-8. Epub 2010 Apr 9. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Enrollment ICMJE | 21 | ||||||||
Completion Date | August 2010 | ||||||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY: Chemotherapy
Radiotherapy
Other
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Gender | Both | ||||||||
Ages | 18 Years to 70 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | Switzerland | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00238407 | ||||||||
Other Study ID Numbers ICMJE | SAKK 76/02, EU-20529 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Swiss Group for Clinical Cancer Research | ||||||||
Study Sponsor ICMJE | Swiss Group for Clinical Cancer Research | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Swiss Group for Clinical Cancer Research | ||||||||
Verification Date | June 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |