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


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Ifosfamide

Ifex



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

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
Carcinoma, Small Cell
 Procedure: chemotherapy
 Procedure: radiation therapy
 Drug: carboplatin
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: etoposide
 Drug: ifosfamide
 Drug: mesna
 Drug: vincristine
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of VICE (Ifosfamide/Carboplatin/Etoposide with Mid-Cycle Vincristine) vs Standard Chemotherapy Followed, as Feasible, by Thoracic Radiotherapy in Patients with Newly Diagnosed Small Cell Lung Cancer and Good Performance Status

Further Study Details: 

Study start: March 1996

OBJECTIVES: I. 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. II. 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. III. 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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Microscopically proven small cell lung cancer

--Prior/Concurrent Therapy--

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)

Location Information


United Kingdom, England
      Medical Research Council Clinical Trials Unit, London,  England,  NW1 2DA,  United Kingdom

Study chairs or principal investigators

David J. Girling,  Study Chair,  Medical Research Council   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064998; MRC-LU21; EU-96019
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002822
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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November 18, 2008



Page Updated: June 1, 2005
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