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Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072033
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm A
Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
Drug: Cisplatin and Docetaxel
cisplatin and docetaxel chemo- and radiochemotherapy

Primary Outcome Measures :
  1. Feasibility of successful study therapy completion and survival after surgery [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 30 days ]
  2. Overall survival [ Time Frame: Life-long ]
  3. Feasibility in Switzerland after surgery [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)

    • Locally advanced disease that is technically operable with curative intent (R0)
    • T3, N0 OR T1-3, N+ OR T4, NX
    • No T1-2, N0
    • No inoperable T4 (unequivocal organ involvement)
    • No distant metastasis, including M1a lymph node status

      • Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
  • No carcinoma of the cervical esophagus
  • Obstructive tumors allowed



  • 18 to 70

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • AST no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin no greater than 1.5 times ULN


  • Creatinine clearance greater than 60 mL/min


  • No New York Heart Association class III or IV congestive heart failure
  • No unstable angina pectoris
  • No myocardial infarction within the past 3 months
  • No significant arrhythmias
  • No other severe or uncontrolled cardiovascular disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after study treatment
  • No definite contraindications to corticosteroids as premedication
  • No geographic situation that would preclude proper staging and follow-up
  • No active uncontrolled infection
  • No preexisting peripheral neuropathy greater than grade 1
  • No uncontrolled diabetes mellitus
  • No active autoimmune disease
  • No other serious medical condition that would preclude study participation
  • No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
  • No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the chest


  • Not specified


  • More than 30 days since prior treatment on another clinical trial
  • No other concurrent experimental drugs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00072033

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Kantonspital Aarau
Aarau, Switzerland, CH-5001
Basel, Switzerland, CH-4031
Inselspital Bern
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
Ospedale Civico
Lugano, Switzerland, CH-6900
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
City Hospital Triemli
Zurich, Switzerland, 8063
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Thomas Ruhstaller, MD Cantonal Hospital of St. Gallen
Publications of Results:
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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00072033    
Other Study ID Numbers: SAKK 75/02
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action