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

A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III Non-Small-Cell-Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00463515

Acronym

CHER@NOS

Enrollment

Registered

2007-04-20

Start date

2003-01-31

Completion date

2006-11-30

Last updated

2013-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell-Lung Cancer

Keywords

Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, lung cancer, induction chemotherapy, chemo-radiotherapy

Brief summary

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.

Interventions

DRUGcarboplatin/gemcitabine

PROCEDUREcisplatin/radiation therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
2-year survival rates	—

Secondary

Measure	Time frame
Response rate	—
Time to intrathoracic failure	—
Overall survival	—
Toxicity of induction chemotherapy	—
Toxicity of chemo-radiotherapy	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026