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

Sponsor:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072033

Purpose

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	Intervention	Phase
Esophageal Cancer	Drug: cisplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pathological complete remission at surgery [ Designated as safety issue: No ]
Feasibility of successful study therapy completion and survival 30 days after surgery [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Early improvement of patient-rated dysphagia as measured by esophageal module of the EORTC QLQ-OES24 at 12 months after surgery [ Designated as safety issue: No ]
Feasibility in Switzerland 30 days after surgery [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	March 2003

Detailed Description:

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072033

Locations

Switzerland
Kantonspital Aarau
Aarau, Switzerland, CH-5001
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Spitaeler Chur AG
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Ospedale Civico
Lugano, Switzerland, CH-6900
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
City Hospital Triemli
Zurich, Switzerland, 8063

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:

Thomas Ruhstaller, MD

Kantonsspital - St. Gallen

More Information

Publications:

Jost C, Binek J, Schuller JC, Bauerfeind P, Metzger U, Werth B, Knuchel J, Frossard JL, Bertschinger P, Brauchli P, Meyenberger C, Ruhstaller T. Endosonographic radial tumor thickness after neoadjuvant chemoradiation therapy to predict response and survival in patients with locally advanced esophageal cancer: a prospective multicenter phase ll study by the Swiss Group for Clinical Cancer Research (SAKK 75/02). Gastrointest Endosc. 2010 Mar 19; [Epub ahead of print]

Klaeser B, Nitzsche E, Schuller JC, Koberle D, Widmer L, Balmer-Majno S, Hany T, Cescato-Wenger C, Brauchli P, Zund M, Pestalozzi BC, Caspar C, Albrecht S, von Moos R, Ruhstaller T. Limited Predictive Value of FDG-PET for Response Assessment in the Preoperative Treatment of Esophageal Cancer: Results of a Prospective Multi-Center Trial (SAKK 75/02). Onkologie. 2009;32(12):724-730. Epub 2009 Nov 9.

Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, Balmermajno S, Köberle D, Terraciano L, Schnider A, Bodis S, Popescu R; for the Swiss Group for Clinical Cancer Research (SAKK). 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. 2009 May 22; [Epub ahead of print]

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.

ClinicalTrials.gov Identifier:	NCT00072033 History of Changes
Other Study ID Numbers:	CDR0000335172, SWS-SAKK-75/02, EU-20323
Study First Received:	November 4, 2003
Last Updated:	March 25, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Head and Neck Neoplasms
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012