Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-11-30

Brief Summary

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The aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.

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Detailed Description

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Conditions

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Non-Small-Cell-Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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carboplatin/gemcitabine

Intervention Type DRUG

cisplatin/radiation therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* cytological or histologically proven NSCLC
* unresectable stage III NSCLC
* presence of at least one measurable lesion (RECIST criteria)
* adequate haematological, renal and hepatic function
* adequate lung function reserve
* good condition, weight loss \<10% over previous 6 months, life expectancy \> 3 months

Exclusion Criteria

* previous chemotherapy for NSCLC
* distant metastasis or a pleural or pericardial effusion
* treatment for malignant disease in the past or serious concomitant medical or psychiatric disease
* active uncontrolled infection at time of inclusion
* interstitial lung disease
* auto-immune systemic disease with potential involvement of the lungs
* concomitant use of amiodarone

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No