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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622349
• Other study ID #: ELCWP-01041
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: January 29, 2013
• Start date: February 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2013
• Source: European Lung Cancer Working Party
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Cisplatin, 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
• Ifosfamide, Gemcitabine
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
• Cisplatin, docetaxel
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks

Locations

Country	Name	City	State
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
France	Pneumology department of CHU Lille	Lille
Greece	Hellenic Cancer Institute - St Savas Oncology Hospital	Athens
Spain	Medical Oncology Hospital de Sagunto	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Survival will be dated from the first day of registration until death or last follow up	Yes
Secondary	Response rate		Every 3 courses of chemotherapy	No
Secondary	Toxicity		After each course of chemotherapy	No
Secondary	Activity of second-line chemotherapy		Every 3 courses of chemotherapy	No

External Links

•   Click here for more information on the protocol
•   Trial registry of the French National Cancer Institute