Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 70	Other	SWS-SAKK-75/02 EU-20323, NCT00072033

Objectives

Primary

1. 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.
2. Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients.

Secondary

1. Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results.
2. 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.
3. Determine the quality of life of patients treated with this regimen.
4. Determine the clinical benefit of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 to 70

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 22-66 patients will be accrued for this study.

Outcomes

Pathological complete remission at surgery
Feasibility of successful study therapy completion and survival 30 days after surgery

Adverse events
Overall survival
Time to progression
Early improvement of patient-rated dysphagia as measured by esophageal module of the EORTC QLQ-OES24 at 12 months after surgery
Feasibility in Switzerland 30 days after surgery

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.

Ruhstaller T, Widmer L, Schuller JC, et al.: Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol 20 (9): 1522-8, 2009.[PUBMED Abstract]

Schuller JC, Balmer-Majno S, Mingrone W, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy (RT) in patients with locally advanced esophageal cancer: final results of the multicenter phase ll trial SAKK 75/02. [Abstract] J Clin Oncol 26 (Suppl 15): A-4550, 2008.

Ribi K, Nitzsche E, Schuller J, et al.: PET scanning and patient reported dysphagia before and after chemotherapy (CT) for prediction of pathological response after CT and chemoradiotherapy (CRT) in patients with locally advanced esophageal cancer (EC): a multicenter phase ll trial of the Swiss. [Abstract] J Clin Oncol 25 (Suppl 18): A-4587, 2007.

Ruhstaller T, Widmer L, Majno SB, et al.: Preoperative induction chemotherapy with docetaxel-cisplatin followed by concurrent docetaxel-cisplatin and radiation therapy in patients with locally advanced esophageal cancer: a prospective, multicenter phase ll trial of the Swiss Group for Clinical Cancer Research. [Abstract] J Clin Oncol 25 (Suppl 18): A-4562, 2007.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Thomas Ruhstaller, MD, Protocol chair		Ph: 41-71-494-2082

Registry Information
Official Title		Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients with Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
Trial Start Date		2003-03-11
Registered in ClinicalTrials.gov		NCT00072033
Date Submitted to PDQ		2003-09-15
Information Last Verified		2006-10-01

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