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

June 2, 2012 updated by: Swiss Group for Clinical Cancer Research

Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Kantonspital Aarau
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Chur, Switzerland, CH-7000
        • Spitaeler Chur AG
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire de Geneve
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Lugano, Switzerland, CH-6900
        • Ospedale Civico
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Zurich, Switzerland, 8063
        • City Hospital Triemli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 70

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • 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

Renal

  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the chest

Surgery

  • Not specified

Other

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of successful study therapy completion and survival after surgery
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 30 days
30 days
Overall survival
Time Frame: Life-long
Life-long
Feasibility in Switzerland after surgery
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 4, 2003

First Submitted That Met QC Criteria

November 5, 2003

First Posted (Estimate)

November 6, 2003

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 2, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 75/02
  • EU-20323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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