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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002822
• Other study ID #: CDR0000064998
• Secondary ID: MRC-LU21EU-96019
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: March 1996
• Est. completion date: November 2005

Study information

• Verified date: December 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• carboplatin

• cisplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• ifosfamide

• mesna

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Medical Research Council Clinical Trials Unit	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Thatcher N, Qian W, Clark PI, Hopwood P, Sambrook RJ, Owens R, Stephens RJ, Girling DJ. Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clin — View Citation

Thatcher N, Qian W, Girling DJ: Ifosfamide, carboplatin and etoposide with mid-cycle vincristine (ICE-V) versus standard chemotherapy (C) in patients with small cell lung cancer (SCLC) and good performance status (PS): results of an MRC randomized trial (