Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

NCT00616785 | Unknown Phase 2

• 2 other identifiers: CDR0000584442YONSEI-4-2007-0120
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (3)

• Rate of local/regional control

• Rate of systemic disease control

• Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy

Secondary Outcomes (3)

• Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0

• Progression-free survival

• Overall survival

Interventions

cisplatin DRUG

etoposide DRUG

irinotecan hydrochloride DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIA (N2) or IIIB disease * Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter * No stage IIIB disease with malignant pleural effusion or superior sulcus tumor * At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors * Unresectable disease * No known brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * ANC ≥ 1,500/mm³ * Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion) * Platelet count ≥ 100,000/mm³ * Creatinine \< 1.5 mg/dL * Total bilirubin \< 2 times upper limit of normal (ULN) * Transaminases \< 3 times ULN * Patient compliance and geographic proximity that allow adequate follow up * No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes) * No history of significant neurological or mental disorder, including seizures or dementia * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * No active cardiac disease not controlled by therapy * No myocardial infarction within the past 12 months PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for NSCLC * No other concurrent systemic chemotherapy, investigational drug, or radiotherapy

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Etoposide; Irinotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• Joo-Hang Kim, MD

  Yonsei University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 15, 2008
• Study Start: June 1, 2007
• Primary Completion: November 1, 2010
• Last Updated: February 9, 2009

Record last verified: 2008-09

Locations

KR (1)