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

Original Study ID : CDR0000064998

Secondary ID : Array

NCT ID : NCT00002822

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

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

Brief Summary :

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.

Source : National Cancer Institute (NCI)

Detailed Description :

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.

Overall Status : Active, not recruiting

Start Date : March 1996

Official Title : Phase 3

Phase : Interventional

Study Design : Treatment, Randomized, Active Control

Enrollment : 400

Verification Date : December 2000

First Received Date : November 1, 1999

Trial 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

Gender : Both

Minimum Age : N/A

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Medical Research Council Clinical Trials Unit

City : London

State : England

Zip Code : NW1 2DA

Country : United Kingdom

Interventions

Type : Drug

Name : carboplatin

Type : Drug

Name : cisplatin

Type : Drug

Name : cyclophosphamide

Type : Drug

Name : doxorubicin hydrochloride

Type : Drug

Name : etoposide

Type : Drug

Name : ifosfamide

Type : Drug

Name : mesna

Type : Drug

Name : vincristine sulfate

Type : Radiation

Name : radiation therapy

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