Search / Trial NCT00002822

Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer

Launched by MEDICAL RESEARCH COUNCIL · Apr 15, 2003

Trial Information

Current as of January 03, 2025

Completed

Keywords

Limited Stage Small Cell Lung Cancer Extensive Stage Small Cell Lung Cancer

ClinConnect Summary

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 re...

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

David J. Girling, MD

Study Chair

Medical Research Council

About Medical Research Council

The Medical Research Council (MRC) is a prominent UK-based organization dedicated to advancing medical research and improving health outcomes through innovative scientific inquiry. As a leading sponsor of clinical trials, the MRC fosters collaboration among researchers, healthcare professionals, and industry partners to facilitate cutting-edge studies that address critical health challenges. With a strong emphasis on evidence-based research, the MRC supports a diverse portfolio of clinical trials aimed at translating scientific discoveries into practical applications, ultimately enhancing patient care and public health. Their commitment to rigorous ethical standards and regulatory compliance ensures the integrity and reliability of the research they sponsor.

Locations

London, England, United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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