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Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002822   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
March 1996
 
 
 
Complete list of historical versions of study NCT00002822 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.

OBJECTIVES:

  • Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.
  • Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.
  • Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.

OUTLINE: This is a randomized study.

The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.

The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.

Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.

Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.

Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.

Phase III
Interventional
Treatment, Randomized, Active Control
Lung Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: ifosfamide
  • Drug: mesna
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
 
Thatcher N, Qian W, Clark PI, Hopwood P, Sambrook RJ, Owens R, Stephens RJ, Girling DJ. Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial. J Clin Oncol. 2005 Nov 20;23(33):8371-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
400
 
 

DISEASE CHARACTERISTICS:

  • Microscopically proven small cell lung cancer

    • Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology
    • No pleural fluid cytology
  • No prior therapy

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • WHO 0-2

Hematopoietic:

  • WBC more than 3,000
  • ANC more than 1,500
  • Platelets more than 100,000

Hepatic/Renal:

  • Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal
  • Creatinine or urea normal
  • Creatinine clearance or GFR more than 65 mL/min

Other:

  • No clinical evidence of infection
  • No prior or concurrent malignancy that interferes with protocol treatments or comparisons
  • No other condition that contraindicates treatment
  • Willing and able to complete quality-of-life questionnaires

    • Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00002822
 
CDR0000064998, MRC-LU21, EU-96019
Medical Research Council
 
Study Chair: David J. Girling, MD Medical Research Council
National Cancer Institute (NCI)
December 2000

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