Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery

June 4, 2012 updated by: Swiss Group for Clinical Cancer Research

Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the local tumor-control rate in patients with locally advanced, unresectable esophageal cancer treated with docetaxel, cisplatin, and radiotherapy.

Secondary

  • Determine the feasibility of this regimen in these patients.
  • Determine the adverse reactions of this regimen in these patients.
  • Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen.
  • Determine overall survival of patients treated with this regimen.
  • Determine the long-term survival rate in patients treated with this regimen.
  • Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen.
  • Determine quality of life and clinical benefit in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3 months for 1 year after completion of study treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

21

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
        • Hirslanden Klinik Aarau
      • Basel, Switzerland, CH-4016
        • Saint Claraspital AG
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Bruderholz, Switzerland, CH-4101
        • Kantonsspital Bruderholz
      • Chur, Switzerland, CH-7000
        • Kantonsspital Graubuenden
      • Liestal, Switzerland, CH-4410
        • Kantonsspital
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Thun, Switzerland, 3600
        • Regionalspital
      • Zurich, Switzerland, CH-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 esophageal cancer, including the gastroesophageal junction

    • Squamous cell or adenocarcinoma
    • Unresectable disease

  • Meets 1 of the following staging criteria by endoscopic ultrasound:

    • Cervical (supraclavicular) lesion, meeting 1 of the following stages:

      • TX, N+ disease
      • T3-4, NX disease
      • TX, NX, M1a* disease

    • Thoracic (celiac) lesion, meeting 1 of the following stages:

      • Unresectable T4, NX disease
      • TX, NX, M1a* disease
    • Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a requires unequivocal abnormality on staging CT scan/endosonography
  • No T1-2, N0 disease
  • All tumors encompassable in 1 radiation field
  • No tumor with esophagotracheal fistula

PATIENT CHARACTERISTICS:

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • AST ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine clearance > 60 mL/min

Cardiovascular

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

Immunologic

  • No uncontrolled active infection
  • No active autoimmune disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No definite contraindication to corticosteroids
  • No uncontrolled diabetes mellitus
  • No pre-existing peripheral neuropathy > grade 1
  • No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
  • No other serious underlying 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

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

Radiotherapy

  • No prior radiotherapy to the chest

Other

  • More than 30 days since prior experimental treatment in 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 I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Drug: Docetaxel and Cisplatin
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.
Radiation: Radiotherapy
Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients without local failure measured 6 months after completion of study treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse reactions measured after completion of study treatment
Time Frame: 6 months
6 months
Successful completion of therapy measured after completion of study treatment
Time Frame: 6 months
6 months
Dysphagia as measured 6 months after completion of study treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Principal Investigator: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen
  • Study Chair: Razvan Popescu, MD, Hirslanden Klinik Aarau

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, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 76/02
  • EU-20529

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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