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Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00030810   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: October 29, 2009   History of Changes

February 14, 2002
October 29, 2009
September 2001
 
Rate of event-free survival measured 1 year after registration [ Designated as safety issue: No ]
Rate of event-free survival measured 1 year after registration
Complete list of historical versions of study NCT00030810 on ClinicalTrials.gov Archive Site
  • Operability after chemotherapy [ Designated as safety issue: No ]
  • Postoperative mortality 30 days after surgery [ Designated as safety issue: No ]
  • Complete resection rate after surgery [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Operability after chemotherapy
  • Postoperative mortality 30 days after surgery
  • Complete resection rate after surgery
  • Toxicity
  • Response rate
 
Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

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.

OBJECTIVES:

  • 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.

Phase II
Interventional
Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: docetaxel
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
 
Stupp R, Mayer M, Kann R, Weder W, Zouhair A, Betticher DC, Roth AD, Stahel RA, Majno SB, Peters S, Jost L, Furrer M, Thierstein S, Schmid RA, Hsu-Schmitz SF, Mirimanoff RO, Ris HB, Pless M. Neoadjuvant chemotherapy and radiotherapy followed by surgery in selected patients with stage IIIB non-small-cell lung cancer: a multicentre phase II trial. Lancet Oncol. 2009 Aug;10(8):785-93. Epub 2009 Jul 13.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
46
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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)

Radiotherapy:

  • No prior radiotherapy to the chest

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since prior treatment in a clinical trial
  • No prior cytostatic therapy
  • No other concurrent experimental drugs
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00030810
 
CDR0000069199, SWS-SAKK-16/01, EU-20137
Swiss Group for Clinical Cancer Research
 
Study Chair: Roger Stupp, MD Centre Hospitalier Universitaire Vaudois
National Cancer Institute (NCI)
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP