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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00072033
First received: November 4, 2003
Last updated: June 2, 2012
Last verified: June 2012
  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 and Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Feasibility of successful study therapy completion and survival after surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Life-long ] [ Designated as safety issue: No ]
  • Feasibility in Switzerland after surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: March 2003
Study Completion Date: May 2010
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
Drug: Cisplatin and Docetaxel
cisplatin and docetaxel chemo- and radiochemotherapy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Cantonal Hospital of St. Gallen
  More Information

Publications:
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.

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00072033     History of Changes
Other Study ID Numbers: SAKK 75/02, EU-20323
Study First Received: November 4, 2003
Last Updated: June 2, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014