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

Phase 2
18 Years
70 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

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



- 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.


- 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

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


- 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



- 18 to 70

Performance status

- WHO 0-1

Life expectancy

- Not specified


- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine clearance greater than 60 mL/min


- 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


- 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


Biologic therapy

- Not specified


- No prior chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy to the chest


- Not specified


- More than 30 days since prior treatment on another clinical trial

- No other concurrent experimental drugs

Type of Study:


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:


Principal Investigator

Thomas Ruhstaller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital St. Gallen


Switzerland: Swissmedic

Study ID:

SAKK 75/02



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