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Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

This study has been completed.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research Identifier:
First received: February 14, 2002
Last updated: May 14, 2012
Last verified: May 2012

RATIONALE: Drugs used in chemotherapy 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. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Condition Intervention Phase
Lung Cancer Radiation: Hyperfractionated Drug: Taxotere/Cisplatin Procedure: conventional surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Rate of event-free survival measured 1 year after registration

Secondary Outcome Measures:
  • Operability after chemotherapy
  • Postoperative mortality 30 days after surgery
  • Complete resection rate after surgery
  • Toxicity
  • Response rate

Enrollment: 46
Study Start Date: September 2001
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Hyperfractionated
    Hyperfractionated radiotherapy
    Drug: Taxotere/Cisplatin
    Procedure: conventional surgery
    conventional surgery
Detailed Description:


  • Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
  • Determine the rate of event-free survival at 1 year in patients treated with this regimen.
  • Determine the operability and complete resection rate in patients treated with this regimen.
  • Determine the postoperative 30-day mortality in patients treated with this regimen.
  • Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed, operable stage IIIB non-small cell lung cancer

    • T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax
    • Squamous cell
    • Adenosquamous cell
    • Large cell
    • Poorly differentiated
  • No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan
  • No malignant pleural or pericardial effusion
  • No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes



  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST and/or ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine clearance at least 60 mL/min


  • No unstable cardiac disease requiring treatment
  • No congestive heart failure
  • No angina pectoris (even if medically controlled)
  • No significant arrhythmia
  • No myocardial infarction within the past 3 months


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No definite contraindications for the use of corticosteroids as premedication
  • No preexisting grade 2 or greater peripheral neuropathy
  • No active uncontrolled infection
  • No uncontrolled diabetes mellitus
  • No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix
  • No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent
  • No other serious underlying medical condition that would preclude study participation
  • No socioeconomic or geographical circumstances that would preclude study compliance


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)


  • No prior radiotherapy to the chest


  • See Disease Characteristics


  • At least 30 days since prior treatment in a clinical trial
  • No prior cytostatic therapy
  • 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 identifier: NCT00030810

Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Roger Stupp, MD Centre Hospitalier Universitaire Vaudois
  More Information

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00030810     History of Changes
Other Study ID Numbers: SAKK 16/01
Study First Received: February 14, 2002
Last Updated: May 14, 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017