Lung Cancer Clinical Trial
Official title:
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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