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CompletedNCT00072033Updated Jun 5, 2012

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

A Phase 2 interventional study of Cisplatin and Docetaxel in Esophageal Cancer, sponsored by Swiss Cancer Institute. Completed at 9 sites in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-06-05.

Sponsored by Swiss Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • stage II esophageal cancer
  • stage III esophageal cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
03

In context

Esophageal Neoplasms

1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.

This study's enrollment of 66 is close to the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Swiss Cancer Institute is the lead sponsor of 27 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    Arm A

    Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery

    Drug: Cisplatin and Docetaxel

Interventions

  • DrugCisplatin and Docetaxel

    Drug pages: Cisplatin · Docetaxel

    cisplatin and docetaxel chemo- and radiochemotherapy

06

What researchers measure

Primary outcomes

  1. Feasibility of successful study therapy completion and survival after surgery

    Time frame: 30 days

Secondary outcomes

  1. Adverse events

    Time frame: 30 days

  2. Overall survival

    Time frame: Life-long

  3. Feasibility in Switzerland after surgery

    Time frame: 30 days

07

Study locations

9 sites
  • Kantonspital Aarau
    Aarau, CH-5001, Switzerland
  • Universitaetsspital-Basel
    Basel, CH-4031, Switzerland
  • Inselspital Bern
    Bern, CH-3010, Switzerland
  • Spitaeler Chur AG
    Chur, CH-7000, Switzerland
  • Hopital Cantonal Universitaire de Geneve
    Geneva, CH-1211, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
  • Ospedale Civico
    Lugano, CH-6900, Switzerland
  • Kantonsspital - St. Gallen
    Sankt Gallen, CH-9007, Switzerland
  • City Hospital Triemli
    Zurich, 8063, Switzerland
08

References and documents

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 Jun;71(7):1114-21. doi: 10.1016/j.gie.2009.12.015. Epub 2010 Mar 20. PubMed 20304399 ↗
  • 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 Dec;32(12):724-30. doi: 10.1159/000251842. Epub 2009 Nov 9. PubMed 20016233 ↗
  • Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; 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 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22. PubMed 19465425 ↗
  • 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.
  • Steffen T, Dietrich D, Schnider A, Kettelhack C, Huber O, Marti WR, Furrer M, Gloor B, Schiesser M, Thierstein S, Brauchli P, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK). Recurrence Patterns and Long-term Results After Induction Chemotherapy, Chemoradiotherapy, and Curative Surgery in Patients With Locally Advanced Esophageal Cancer. Ann Surg. 2019 Jan;269(1):83-87. doi: 10.1097/SLA.0000000000002435. PubMed 28742685 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00072033
Lead sponsor
Swiss Cancer Institute
Responsible party
Sponsor
First posted
Nov 6, 2003
Start date
Mar 2003
Primary completion
Mar 2003
Completion
May 2010
Last update
Jun 5, 2012

Study contacts

Thomas Ruhstaller, MD
study chair · Cantonal Hospital of St. Gallen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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