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

NCT ID: NCT00039039

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29

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.

Detailed Description

OBJECTIVES:

• Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel.
• Compare the 1-year survival rate and mean survival time in patients treated with these regimens.
• Compare the objective response rate and local control in patients treated with these regimens.
• Compare the tolerability of these regimens in these patients.
• Compare the safety profile and toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment.

• Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks.
• Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Conditions

Lung Cancer

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

chemotherapy

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Principal Investigators

Paolo Bruzzi, MD, MPH, PhD

Role: STUDY_CHAIR

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

Locations

Ospedale Civile di Asti

Asti, , Italy

Centro di Riferimento Oncologico - Aviano

Aviano, , Italy

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Spedali Civili di Brescia

Brescia, , Italy

Civic Hospital of Carrara

Carrara, , Italy

Ospedale Regionale A. Pugliese

Catanzaro, , Italy

Ospedale Mariano Santo

Cosenza, , Italy

Azienda Istituti Ospitalieri

Cremona, , Italy

Ospedale Santa Croce

Cuneo, , Italy

Ospedale Galliera Oncologia

Genoa, , Italy

Istituto Nazionale per la Ricerca sul Cancro

Genoa, , Italy

Ospedale San Martino

Genoa, , Italy

Ospedale Civile di Ivrea

Ivrea, , Italy

Ospedale Santa Maria Goretti

Latina, , Italy

Ospedale Umberto I

Lugo DI Romagna, , Italy

Istituto Policlinico San Donato

Milan, , Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, , Italy

University of Modena Hospital and Reggio Emilia School of Medicine

Modena, , Italy

Nuovo Ospedale San Gerardo at University of Milano-Bicocca

Monza, , Italy

Azienda Ospedale S. Luigi at University of Torino

Orbassano, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Azienda Ospedaliera Di Parma

Parma, , Italy

Policlinico Monteluce

Perugia, , Italy

Ospedale Santa Chiara Pisa

Pisa, , Italy

Ospedale Sta. Maria Delle Croci

Ravenna, , Italy

Ospedale Carlo Forlanini

Rome, , Italy

Ospedale S. Camillo-Forlanini

Rome, , Italy

Azienda Policlinico Umberto Primo

Rome, , Italy

Istituti Fisioterapici Ospitalieri - Roma

Rome, , Italy

Istituto Regina Elena

Rome, , Italy

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Azienda Ospedaliera S. Maria

Terni, , Italy

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, , Italy

Ospedale Evangelico Valdese

Turin, , Italy

Ospedale Ostetrico Ginecologica Sant Anna

Turin, , Italy

Azienda Ospedaliera Santa Maria della Misericordia

Udine, , Italy

Ospedale San Bortolo

Vicenza, , Italy

Countries

Italy

Other Identifiers

INRC-PITCAP

Identifier Type: -

Identifier Source: secondary_id

EU-20202

Identifier Type: -

Identifier Source: secondary_id

INRC-ITA

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1665

Identifier Type: -

Identifier Source: secondary_id

CDR0000068846

Identifier Type: -

Identifier Source: org_study_id