Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

NCT00021112 | Terminated Phase 2

• 1 other identifier: EORTC-08981
• Study Type: interventional
• Target: 5
• Locations: 4 countries
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer

Interventions

cisplatin DRUG

etoposide DRUG

conventional surgery PROCEDURE

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 primary stage IIIB non-small cell lung cancer (NSCLC) * T4, any N, M0 or any T, N3, M0 * No N3 disease due to scalene or supraclavicular lymph node involvement * No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement * No mixed tumor types with small cell lung cancer * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No pre-existing pleural or pericardial effusion * No CNS involvement by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm \^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.25 times ULN * Creatinine clearance at least 60 mL/min Cardiovascular: * No clinical evidence of superior vena cava syndrome Pulmonary: * Postoperative FEV1 and KCO greater than 40% predicted * VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted) Other: * No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma) * No active uncontrolled infection requiring IV antibiotics * No pre-existing sensory neurotoxicity grade 2 or greater * No psychological, familial, sociological, or geographical condition that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for NSCLC * No concurrent immunotherapy during induction chemoradiotherapy * Concurrent colony stimulating factors allowed Chemotherapy: * No prior chemotherapy for NSCLC Endocrine therapy: * No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * No prior surgery for NSCLC Other: * No other concurrent anticancer drugs during induction chemoradiotherapy

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (10)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Thoraxklinik Rohrbach

Heidelberg, D-69126, Germany

Location

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, 7334 DZ, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3000 CA, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

National Institute of Tuberculosis and Lung Diseases

Warsaw, Poland

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Etoposide; 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; Therapeutics

Study Officials

• Rob Van Klaveren, MD, PhD

  University Medical Center Rotterdam at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: October 1, 2002
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

BE (2); DE (1); PL (2); NL (5)