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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00238407
First received: October 12, 2005
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: Docetaxel and Cisplatin
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Proportion of patients without local failure measured 6 months after completion of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: March 2004
Study Completion Date: August 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238407

Locations
Switzerland
Hirslanden Klinik Aarau
Aarau, Switzerland, CH-5001
Saint Claraspital AG
Basel, Switzerland, CH-4016
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Kantonsspital
Liestal, Switzerland, CH-4410
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
City Hospital Triemli
Zurich, Switzerland, CH-8063
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Razvan Popescu, MD Hirslanden Klinik Aarau
Principal Investigator: Thomas Ruhstaller, MD Cantonal Hospital of St. Gallen
  More Information

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00238407     History of Changes
Other Study ID Numbers: SAKK 76/02, EU-20529
Study First Received: October 12, 2005
Last Updated: June 4, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014