Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
Sponsor study identifier
Secondary identifiers
interventional
66
1 country
9
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2003
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
March 2003
Actual (reported)November 4, 2003
Actual (reported)November 6, 2003
Actual (reported)May 2010
Actual (reported)Feasibility of successful study therapy completion and survival after surgery
30 days
Adverse events
30 days
Overall survival
Life-long
Feasibility in Switzerland after surgery
30 days
Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
cisplatin and docetaxel chemo- and radiochemotherapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Cisplatin and Docetaxel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordKantonspital Aarau
Aarau, CH-5001, Switzerland
Universitaetsspital-Basel
Basel, CH-4031, Switzerland
Inselspital Bern
Bern, CH-3010, Switzerland
Spitaeler Chur AG
Chur, CH-7000, Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011, Switzerland
Ospedale Civico
Lugano, CH-6900, Switzerland
Jost C, Binek J, Schuller JC, Bauerfeind P, Metzger U, Werth B, Knuchel J, Frossard JL, Bertschinger P, Brauchli P, Meyenberger C, Ruhstaller T. Endosonographic radial tumor thickness after neoadjuvant chemoradiation therapy to predict response and survival in patients with locally advanced esophageal cancer: a prospective multicenter phase ll study by the Swiss Group for Clinical Cancer Research (SAKK 75/02). Gastrointest Endosc. 2010 Jun;71(7):1114-21. doi: 10.1016/j.gie.2009.12.015. Epub 2010 Mar 20.
Klaeser B, Nitzsche E, Schuller JC, Koberle D, Widmer L, Balmer-Majno S, Hany T, Cescato-Wenger C, Brauchli P, Zund M, Pestalozzi BC, Caspar C, Albrecht S, von Moos R, Ruhstaller T. Limited predictive value of FDG-PET for response assessment in the preoperative treatment of esophageal cancer: results of a prospective multi-center trial (SAKK 75/02). Onkologie. 2009 Dec;32(12):724-30. doi: 10.1159/000251842. Epub 2009 Nov 9.
Thomas Ruhstaller, MD
Cantonal Hospital of St. Gallen
66 participants (actual enrollment reported by the registry).
First Submitted
November 4, 2003
First Posted
November 6, 2003
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007, Switzerland
City Hospital Triemli
Zurich, 8063, Switzerland
Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22.
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.
Steffen T, Dietrich D, Schnider A, Kettelhack C, Huber O, Marti WR, Furrer M, Gloor B, Schiesser M, Thierstein S, Brauchli P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK). Recurrence Patterns and Long-term Results After Induction Chemotherapy, Chemoradiotherapy, and Curative Surgery in Patients With Locally Advanced Esophageal Cancer. Ann Surg. 2019 Jan;269(1):83-87. doi: 10.1097/SLA.0000000000002435.
Primary Completion
March 2003
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
June 5, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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