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

NCT00002822 | Completed Phase 3

• 3 other identifiers: CDR0000064998MRC-LU21EU-96019
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer; extensive stage small cell lung cancer

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

mesna DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Related 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: 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. doi: 10.1200/JCO.2004.00.9969.

  PMID: 16293867 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Ifosfamide; Mesna; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• David J. Girling, MD

  Medical Research Council

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 16, 2003
• Study Start: March 1, 1996
• Study Completion: November 1, 2005
• Last Updated: December 19, 2013

Record last verified: 2000-12

Locations

GB (1)