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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cisplatin, Ifosfamide, Gemcitabine
Ifosfamide, Gemcitabine
Cisplatin, docetaxel
Sponsored by
European Lung Cancer Working Party
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Randomised phase III, Chemotherapy, Advanced non-small cell lung carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
  • Pneumology department of CHU Lille
  • Hellenic Cancer Institute - St Savas Oncology Hospital
  • Medical Oncology Hospital de Sagunto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Response rate
Toxicity
Activity of second-line chemotherapy

Full Information

First Posted
February 14, 2008
Last Updated
January 29, 2013
Sponsor
European Lung Cancer Working Party
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1. Study Identification

Unique Protocol Identification Number
NCT00622349
Brief Title
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
Official Title
A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Lung Cancer Working Party

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Randomised phase III, Chemotherapy, Advanced non-small cell lung carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
707 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cisplatin, Ifosfamide, Gemcitabine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ifosfamide, Gemcitabine
Intervention Description
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin, docetaxel
Intervention Description
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
Primary Outcome Measure Information:
Title
Survival
Time Frame
Survival will be dated from the first day of registration until death or last follow up
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
Every 3 courses of chemotherapy
Title
Toxicity
Time Frame
After each course of chemotherapy
Title
Activity of second-line chemotherapy
Time Frame
Every 3 courses of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Sculier, MD, PhD
Organizational Affiliation
European Lung Cancer Working Party
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Pneumology department of CHU Lille
City
Lille
Country
France
Facility Name
Hellenic Cancer Institute - St Savas Oncology Hospital
City
Athens
Country
Greece
Facility Name
Medical Oncology Hospital de Sagunto
City
Valencia
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.e-cancer.fr
Description
Trial registry of the French National Cancer Institute

Learn more about this trial

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

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