Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer - Full Text View

Sponsored by:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002822

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

Drug Information available for: Cyclophosphamide Vincristine Cisplatin Mesna Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Myocet Etoposide phosphate Vincristine sulfate Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	400
Study Start Date:	March 1996

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002822

Locations

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

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

David J. Girling, MD

Medical Research Council

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial. J Clin Oncol. 2005 Nov 20;23(33):8371-9.

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 (LU21). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2489, 619, 2003.

Study ID Numbers:	CDR0000064998, MRC-LU21, EU-96019
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002822 History of Changes
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

Study placed in the following topic categories:

Thoracic Neoplasms
Immunologic Factors
Carcinoma, Neuroendocrine
Cyclophosphamide
Etoposide phosphate
Anti-Bacterial Agents
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Alkylating Agents
Etoposide
Vincristine
Antimitotic Agents

Carboplatin
Immunosuppressive Agents
Doxorubicin
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Ifosfamide
Lung Diseases
Mechlorethamine
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Adenocarcinoma
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Alkylating Agents

Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Vincristine
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Pharmacologic Actions
Doxorubicin
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009