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| Sponsored by: |
Swiss Group for Clinical Cancer Research |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072033 |
Purpose
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: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.
| Condition | Intervention | Phase |
|
Esophageal Cancer |
Drug: cisplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders |
| ChemIDplus related topics: | Cisplatin Docetaxel |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial |
| Estimated Enrollment: | 66 |
| Study Start Date: | March 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
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
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
No distant metastasis, including M1a lymph node status
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Switzerland | |||||
| Centre Hospitalier Universitaire Vaudois | |||||
| Lausanne, Switzerland, CH-1011 | |||||
| City Hospital Triemli | |||||
| Zurich, Switzerland, 8063 | |||||
| Hopital Cantonal Universitaire de Geneve | |||||
| Geneva, Switzerland, CH-1211 | |||||
| Inselspital Bern | |||||
| Bern, Switzerland, CH-3010 | |||||
| Universitaetsspital-Basel | |||||
| Basel, Switzerland, CH-4031 | |||||
| Kantonsspital - St. Gallen | |||||
| St. Gallen, Switzerland, CH-9007 | |||||
| Ospedale Civico | |||||
| Lugano, Switzerland, CH-6900 | |||||
| Spitaeler Chur AG | |||||
| Chur, Switzerland, CH-7000 | |||||
| Kantonspital Aarau | |||||
| Aarau, Switzerland, CH-5001 | |||||
| Swiss Group for Clinical Cancer Research |
| Study Chair: | Thomas Ruhstaller, MD | Kantonsspital - St. Gallen |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Schuller JC, Balmer-Majno S, Mingrone W, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy (RT) in patients with locally advanced esophageal cancer: final results of the multicenter phase ll trial SAKK 75/02. [Abstract] J Clin Oncol 26 (Suppl 15): A-4550, 2008. |
| Ribi K, Nitzsche E, Schuller J, et al.: PET scanning and patient reported dysphagia before and after chemotherapy (CT) for prediction of pathological response after CT and chemoradiotherapy (CRT) in patients with locally advanced esophageal cancer (EC): a multicenter phase ll trial of the Swiss. [Abstract] J Clin Oncol 25 (Suppl 18): A-4587, 2007. |
| Ruhstaller T, Widmer L, Majno SB, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy in patients with locally advanced esophageal cancer: a prospective, multicenter phase ll trial of the Swiss Group for Clinical Cancer Research. [Abstract] J Clin Oncol 25 (Suppl 18): A-4562, 2007. |
| Study ID Numbers: | CDR0000335172, SWS-SAKK-75/02, EU-20323 |
| First Received: | November 4, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00072033 |
| Health Authority: | United States: Federal Government |
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