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Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
This study has been completed.
Study NCT00238407   Information provided by Swiss Group for Clinical Cancer Research

First Received on October 12, 2005.   Last Updated on June 4, 2012   History of Changes

October 12, 2005
June 4, 2012
March 2004
February 2008   (final data collection date for primary outcome measure)
Proportion of patients without local failure measured 6 months after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of patients without local failure measured 6 months after completion of study treatment
Complete list of historical versions of study NCT00238407 on ClinicalTrials.gov Archive Site
  • Adverse reactions measured after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Successful completion of therapy measured after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Dysphagia as measured 6 months after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adverse reactions measured after completion of study treatment
  • Successful completion of therapy measured after completion of study treatment
  • Local failure
  • Distant failure
  • Dysphagia as measured 6 months after completion of study treatment
 
 
 
Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • 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.
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.
Interventions:
  • Drug: Docetaxel and Cisplatin
  • Radiation: Radiotherapy
Ruhstaller T, Templeton A, Ribi K, Schuller JC, Borner M, Thierstein S, von Moos R, Pederiva S, Lohri A, Lombriser N, von Briel C, Koeberle D, Popescu R. Intense therapy in patients with locally advanced esophageal cancer beyond hope for surgical cure: a prospective, multicenter phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 76/02). Onkologie. 2010;33(5):222-8. Epub 2010 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2010
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00238407
SAKK 76/02, EU-20529
Yes
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
 
Study Chair: Razvan Popescu, MD Hirslanden Klinik Aarau
Principal Investigator: Thomas Ruhstaller, MD Kantonsspital - St. Gallen
Swiss Group for Clinical Cancer Research
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP