Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
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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.
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Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients.
Secondary
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Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results.
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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.
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Determine the quality of life of patients treated with this regimen.
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Determine the clinical benefit of this regimen in these patients.
OUTLINE: This is a multicenter study.
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Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery |
Drug: Cisplatin and Docetaxel
cisplatin and docetaxel chemo- and radiochemotherapy
|
Outcome Measures
Primary Outcome Measures
- Feasibility of successful study therapy completion and survival after surgery [30 days]
Secondary Outcome Measures
- Adverse events [30 days]
- Overall survival [Life-long]
- Feasibility in Switzerland after surgery [30 days]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
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Locally advanced disease that is technically operable with curative intent (R0)
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T3, N0 OR T1-3, N+ OR T4, NX
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No T1-2, N0
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No inoperable T4 (unequivocal organ involvement)
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No distant metastasis, including M1a lymph node status
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Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
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No carcinoma of the cervical esophagus
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Obstructive tumors allowed
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
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Neutrophil count at least 1,500/mm^3
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Platelet count at least 100,000/mm^3
Hepatic
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AST no greater than 1.5 times upper limit of normal (ULN)
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Alkaline phosphatase no greater than 2.5 times ULN
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Bilirubin no greater than 1.5 times ULN
Renal
- Creatinine clearance greater than 60 mL/min
Cardiovascular
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No New York Heart Association class III or IV congestive heart failure
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No unstable angina pectoris
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No myocardial infarction within the past 3 months
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No significant arrhythmias
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No other severe or uncontrolled cardiovascular disease
Other
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception during and for 12 months after study treatment
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No definite contraindications to corticosteroids as premedication
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No geographic situation that would preclude proper staging and follow-up
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No active uncontrolled infection
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No preexisting peripheral neuropathy greater than grade 1
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No uncontrolled diabetes mellitus
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No active autoimmune disease
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No other serious medical condition that would preclude study participation
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No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
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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
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More than 30 days since prior treatment on another clinical trial
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No other concurrent experimental drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kantonspital Aarau | Aarau | Switzerland | CH-5001 | |
| 2 | Universitaetsspital-Basel | Basel | Switzerland | CH-4031 | |
| 3 | Inselspital Bern | Bern | Switzerland | CH-3010 | |
| 4 | Spitaeler Chur AG | Chur | Switzerland | CH-7000 | |
| 5 | Hopital Cantonal Universitaire de Geneve | Geneva | Switzerland | CH-1211 | |
| 6 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | CH-1011 | |
| 7 | Ospedale Civico | Lugano | Switzerland | CH-6900 | |
| 8 | Kantonsspital - St. Gallen | St. Gallen | Switzerland | CH-9007 | |
| 9 | City Hospital Triemli | Zurich | Switzerland | 8063 |
Sponsors and Collaborators
- Swiss Group for Clinical Cancer Research
Investigators
- Study Chair: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAKK 75/02
- EU-20323