Spots Global Cancer Trial Database for CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

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Trial Identification

Brief Title: CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

Official Title: Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)

Study ID: NCT00526643

Conditions

Non-Small Cell Lung Cancer

Interventions

gemcitabine

cisplatin

Study Description

Brief Summary: The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.

Detailed Description: Performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer (NSCLC), regardless of treatment received. Chemotherapy is recommended for advanced NSCLC patients in good clinical condition, but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition (performance status 2). This category of patients represents about 20% of all patients at initial diagnosis of NSCLC, and remains a treatment challenge for the clinician. There have been very few studies that have evaluated the impact of chemotherapy for this group of patients, and there is no established standard therapy. Studies evaluating single agent and combination two-agent chemotherapy regimens' impact on survival and improving symptoms are needed.

Keywords

combination chemotherapy

poor performance status

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica, Monteforte Irpino, AV, Italy

Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica, Acquaviva delle Fonti, BA, Italy

Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale, Bari, BA, Italy

Istituto Scientifico S. Raffaele, Milano, MI, Italy

Azienda Ospedaliera C. Poma, Mantova, MN, Italy

Istituto Oncologico Veneto, Padova, PD, Italy

Ospedale E. Morelli, Sondalo, SO, Italy

Ospedale Senatore Antonio Perrino, Brindisi, , Italy

A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia, Catanzaro, , Italy

Ospedale F. Veneziale, Isernia, , Italy

A.O. Vito Fazzi, Lecce, , Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, , Italy

Ospedale Regional, Unità Operative di Oncologia, Parma, , Italy

Ospedale San Camillo - Forlanini, Rome, , Italy

Ospedale S. Felice a Cancello, San Felice a Cancello, , Italy