Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer

NCT00003364 | Completed Phase 3

• 3 other identifiers: CDR0000066349LLCG-TR8SCLCEU-98011
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 14

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with radiation therapy may kill more tumor cells. The best timing for radiation therapy and combination chemotherapy in treating limited stage small cell lung cancer is not yet known . PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Interventions

cisplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer Limited disease defined as within the hemithorax, mediastinum, or ipsilateral supraclavicular nodes No evidence of extensive disease (i.e., contralateral lung or contralateral supraclavicular nodes) No metastatic disease Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: Under 75 Performance status: ECOG 0-3 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine normal OR Creatinine clearance greater than 50 mL/min OR Pentetic acid/ethylenediaminetetraacetic acid clearance greater than 70 mL/min Cardiovascular: No myocardial infarction in the 3 months prior to diagnosis No pericardial effusion Pulmonary: No pleural effusion seen on chest x-ray Pleural effusion identified on CT allowed, if not visible on chest x-ray Other: No medical condition that excludes the use of chemotherapy or thoracic irradiation Must be able to tolerate the prescribed study radiotherapy No other malignant tumor for at least 3 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent prednisone or other corticosteroids for hypercalcemia allowed Radiotherapy: No prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

• London Lung Cancer Group: lead

Study Sites (14)

Heatherwood Hospital

Ascot, England, SL5 8AA, United Kingdom

Location

Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, England, CM1 5ET, United Kingdom

Location

Essex County Hospital

Colchester, England, United Kingdom

Location

Royal Free Hospital

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Guy's and St. Thomas' Hospitals Trust

London, England, SE1 9RT, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, United Kingdom

Location

Related Publications (1)

• Spiro SG, James LE, Rudd RM, Trask CW, Tobias JS, Snee M, Gilligan D, Murray PA, Ruiz de Elvira MC, O'Donnell KM, Gower NH, Harper PG, Hackshaw AK; London Lung Cancer Group. Early compared with late radiotherapy in combined modality treatment for limited disease small-cell lung cancer: a London Lung Cancer Group multicenter randomized clinical trial and meta-analysis. J Clin Oncol. 2006 Aug 20;24(24):3823-30. doi: 10.1200/JCO.2005.05.3181.

  PMID: 16921033 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Stephen G. Spiro

  University College London Hospitals

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 23, 2004
• Study Start: January 1, 1993
• Study Completion: August 1, 2006
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

GB (14)