Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

NCT00039039 | Unknown Phase 3

• 5 other identifiers: CDR0000068846INRC-PITCAPEU-20202INRC-ITANCI-V01-1665
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 37

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. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

Secondary Outcomes (4)

• One-year survival rate and mean survival time

• Objective response rate and local control

• Tolerability

• Safety profile, in terms of acute and delayed toxicity

Interventions

carboplatin DRUG

chemotherapy DRUG

cisplatin DRUG

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) * Locoregionally advanced unresectable disease * Previously untreated * Measurable disease * No involvement of supraclavicular lymph nodes * No cytologically positive pleural or pericardial effusion * No invasion to the wall of the esophagus or the cardiac ventricle * No bone marrow involvement * No distant metastases PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * WHO 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * WBC greater than 4,000/mm\^3 * Absolute neutrophil count greater than 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin less than upper limit of normal (ULN) * AST and ALT less than 2.5 times ULN * Alkaline phosphatase less than 5 times ULN * No hepatic abnormalities Renal: * Creatinine less than ULN Cardiovascular: * No myocardial infarction within the past 6 months * No cardiac insufficiency * No uncontrolled arrhythmia Pulmonary: * FEV1 greater than 1 L * DLCO at least 30% predicted * No pneumonia * No other non-disease-related pulmonary complications Other: * No more than 10% of total weight loss over the past 6 months * No other disease that would preclude study * No peripheral neuropathy grade 3 or greater * No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No familial, geographic, or psychological condition that would preclude study * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy * No concurrent immunotherapy Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * No concurrent endocrine therapy Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * See Disease Characteristics * No prior complete resection of tumor * Prior radical surgical resection allowed if local recurrence of disease * No concurrent major surgery Other: * No other concurrent anticancer therapy or investigational agents

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: lead

Study Sites (37)

Ospedale Civile di Asti

Asti, 14100, Italy

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Spedali Civili di Brescia

Brescia, 25133, Italy

Location

Civic Hospital of Carrara

Carrara, I-54033, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Ospedale Mariano Santo

Cosenza, 87100, Italy

Location

Azienda Istituti Ospitalieri

Cremona, 26100, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Ospedale Galliera Oncologia

Genoa, 16100, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Ospedale San Martino

Genoa, 16132, Italy

Location

Ospedale Civile di Ivrea

Ivrea, 10015, Italy

Location

Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

Ospedale Umberto I

Lugo DI Romagna, 48022, Italy

Location

Istituto Policlinico San Donato

Milan, 20097, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

University of Modena Hospital and Reggio Emilia School of Medicine

Modena, 41100, Italy

Location

Nuovo Ospedale San Gerardo at University of Milano-Bicocca

Monza, 20052, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, 10043, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

Policlinico Monteluce

Perugia, 06122, Italy

Location

Ospedale Santa Chiara Pisa

Pisa, 56100, Italy

Location

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

Location

Ospedale Carlo Forlanini

Rome, 00149, Italy

Location

Ospedale S. Camillo-Forlanini

Rome, 00152, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Istituto Regina Elena

Rome, 00161, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Azienda Ospedaliera S. Maria

Terni, 051100, Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10123, Italy

Location

Ospedale Evangelico Valdese

Turin, 10125, Italy

Location

Ospedale Ostetrico Ginecologica Sant Anna

Turin, 10125, Italy

Location

Azienda Ospedaliera Santa Maria della Misericordia

Udine, 33100, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Drug Therapy; Cisplatin; Paclitaxel; 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)

Coordination Complexes; Organic Chemicals; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Paolo Bruzzi, MD, MPH, PhD

  IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2006-08

Locations

IT (37)