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| ID | Type | Description | Link |
|---|---|---|---|
| EU-20529 |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel and Cisplatin | Drug | Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients without local failure measured 6 months after completion of study treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions measured after completion of study treatment | 6 months | |
| Successful completion of therapy measured after completion of study treatment | 6 months | |
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DISEASE CHARACTERISTICS:
Histologically confirmed esophageal cancer, including the gastroesophageal junction
Meets 1 of the following staging criteria by endoscopic ultrasound:
Cervical (supraclavicular) lesion, meeting 1 of the following stages:
Thoracic (celiac) lesion, meeting 1 of the following stages:
Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a requires unequivocal abnormality on staging CT scan/endosonography
No T1-2, N0 disease
All tumors encompassable in 1 radiation field
No tumor with esophagotracheal fistula
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Other
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| Name | Affiliation | Role |
|---|---|---|
| Razvan Popescu, MD | Hirslanden Klinik Aarau | Study Chair |
| Thomas Ruhstaller, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirslanden Klinik Aarau | Aarau | CH-5001 | Switzerland | |||
| Saint Claraspital AG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20502056 | Result | 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. doi: 10.1159/000305094. Epub 2010 Apr 9. |
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| Radiotherapy | Radiation | Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. |
|
| Dysphagia as measured 6 months after completion of study treatment |
| 6 months |
| Basel |
| CH-4016 |
| Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| Kantonsspital Graubuenden | Chur | CH-7000 | Switzerland |
| Kantonsspital | Liestal | CH-4410 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
| City Hospital Triemli | Zurich | CH-8063 | Switzerland |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
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