Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT00072033|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 5, 2012
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 or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Cisplatin and Docetaxel||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||May 2010|
Active Comparator: Arm A
Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
Drug: Cisplatin and Docetaxel
cisplatin and docetaxel chemo- and radiochemotherapy
- Feasibility of successful study therapy completion and survival after surgery [ Time Frame: 30 days ]
- Adverse events [ Time Frame: 30 days ]
- Overall survival [ Time Frame: Life-long ]
- Feasibility in Switzerland after surgery [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072033
|Aarau, Switzerland, CH-5001|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Spitaeler Chur AG|
|Chur, Switzerland, CH-7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Lugano, Switzerland, CH-6900|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Study Chair:||Thomas Ruhstaller, MD||Cantonal Hospital of St. Gallen|