Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: mesna Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 400 |
| Study Start Date: | March 1996 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Medical Research Council Clinical Trials Unit | |
| London, England, United Kingdom, NW1 2DA | |
| Study Chair: | David J. Girling, MD | Medical Research Council |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002822 History of Changes |
| Other Study ID Numbers: | CDR0000064998, MRC-LU21, EU-96019 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
limited stage small cell lung cancer extensive stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Etoposide phosphate Isophosphamide mustard Cisplatin Cyclophosphamide Doxorubicin |
Etoposide Ifosfamide Vincristine Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013