RANDOMIZED STUDY OF PHASE III OF CARBOPLATIN, PACLITAXEL AND THORAXIC RADIOTHERAPY WITH OR WITHOUT TALIDOMIDE IN PATIENTS WITH CLINICAL STAGE III NSCLC

Phase 1

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-104-03
• Lead Sponsor: EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-02-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Newly diagnosed histological and confirmed non-small cell bronchogenic carcinoma.
Patients must have either unresectable Stage MIA disease or Stage MIB disease without significant pleural effusion. Unresectable.

Exclusion Criteria

Los pacientes no deben estar embarazadas o amamantando debido a los conocidos efectos teratogenicos de la Thaidomida.
Las pacientes femeninas que tienen alguna posibilidad de quedar embarazadas deben tener un
prueba de embarazo realizada dentro de las 24 horas del comienzo de la thaidomida, semanalmente durante las primeras 4 semanas de tratamiento, y luego cada 4 semanas si los periodos de los pacientes son regulares o cada 2 semanas si no lo son. Las mujeres en edad fertil y los varones sexualmente activos deben usar dos metodos anticonceptivos aceptados y efectivos.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:time of life<br><br>Measure:survival and time to progression of patients with stage IIIA or IIIB NSCLC, receiving induction chemotherapy and concurrent chemoradiotherapy with or without thalidomide.<br>Timepoints:6 meses<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:not contemplated<br>Measure:not contemplated<br>Timepoints:not contemplated<br>