Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
18 Years
70 Years
Both
Esophageal Cancer
Trial Information
Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of successful study therapy completion and survival after surgery
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Thomas Ruhstaller, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kantonsspital St. Gallen
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 75/02
NCT ID:
NCT00072033
Start Date:
March 2003
Completion Date:
May 2010
Related Keywords:
- Esophageal Cancer
- stage II esophageal cancer
- stage III esophageal cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- Esophageal Diseases
- Esophageal Neoplasms
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