Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00622349

Enrollment

707

Registered

2008-02-25

Start date

2004-02-29

Completion date

2009-12-31

Last updated

2013-01-30

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Randomised phase III, Chemotherapy, Advanced non-small cell lung carcinoma

Brief summary

The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Interventions

DRUGCisplatin, Ifosfamide, Gemcitabine

Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks

DRUGIfosfamide, Gemcitabine

Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks

DRUGCisplatin, docetaxel

Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histological or cytological diagnosis of non-small cell lung cancer * Advanced (unresectable or functionally inoperable) stage III or stage IV disease * Availability for participating in the detailed follow-up of the protocol * Presence of an evaluable or measurable lesion * Informed consent

Exclusion criteria

* Prior treatment with chemotherapy * Operable patient with resectable tumour * Performance status \< 60 on the Karnofsky scale * A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) * Polynuclear cells \< 2,000/mm³ * Platelet cells \< 100,000/mm³ * Serum bilirubin \>1.5 mg/100 ml * Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min * Perception hypoacousia * Peripheral neuropathy * Recent myocardial infarction (less than 3 months prior to date of diagnosis) * Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia * Uncontrolled infectious disease * Serious medical or psychological factors which may prevent adherence to the treatment schedule

Design outcomes

Primary

Measure	Time frame
Survival	Survival will be dated from the first day of registration until death or last follow up

Secondary

Measure	Time frame
Response rate	Every 3 courses of chemotherapy
Toxicity	After each course of chemotherapy
Activity of second-line chemotherapy	Every 3 courses of chemotherapy

Countries

Belgium, France, Greece, Spain

Outcome results

None listed

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