Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC

Summary

Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung cancer (NSCLC) locally advanced unresectable

Conditions

• Lung Cancer

Interventions

DRUG

Vinorelbine

Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)

DRUG

Cisplatin

Cycle 1 and 2 day 1, 80 mg/m2

DRUG

Vinorelbine

Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)

DRUG

Cisplatin

Cycle 3 and 4 day 1, 80 mg/m2

RADIATION

Radiotherapy

concomitant therapy during cycles 3 and 4. Total dose: 66Gy

Sponsors & Collaborators

• Spanish Lung Cancer Group

  lead OTHER

Principal Investigators

• Mariano Provencio, MD · Hospital Puerta de Hierro

• Bartomeu Massutí, MD · Hospital General Universitario de Alicante

• Teresa Morán, MD · Germans Trias i Pujol Hospital

• José Luis González Larriba, MD · Hospital San Carlos, Madrid

• Manuel Dómine, MD · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

• José Miguel Sánchez, MD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

• Ramón de las Peñas, MD · Hospital Provincial de Castellón

• María Guirado, MD · Hospital Gnral de Elche

• Dolores Isla, MD · Hospital Lozano Blesa

• Raquel Marsé, MD · Hospital Son Espases

• Mª Angeles Sala, MD · Hospital de Basurto

• Juan Coves, MD · Hospital Son Llátzer

• Ana Laura Ortega, MD · Hospital de Jaén

• David Vicente, MD · Hospital Universitario Virgen Macarena

• Regina Gironés, MD · Hospital LLuís Alcanyís

• Alfredo Paredes, MD · Hospital de Donostia

• Margarita Majem, MD · Hospital Sant Pau i de la Santa Creu

• Sergio Vázquez, MD · Hospital Lucus Agustí

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-15

Primary Completion

2019-04-15

Completion

2019-12-16

Countries

• Spain

Study Locations