NCT00622349

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
707

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_3

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

5.1 years

First QC Date

February 14, 2008

Last Update Submit

January 29, 2013

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Randomised phase IIIChemotherapyAdvanced non-small cell lung carcinoma

Outcome Measures

Primary Outcomes (1)

  • Survival

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

Secondary Outcomes (3)

  • Response rate

    Every 3 courses of chemotherapy

  • Toxicity

    After each course of chemotherapy

  • Activity of second-line chemotherapy

    Every 3 courses of chemotherapy

Study Arms (3)

A

EXPERIMENTAL
Drug: Cisplatin, Ifosfamide, Gemcitabine

B

ACTIVE COMPARATOR
Drug: Ifosfamide, Gemcitabine

C

EXPERIMENTAL
Drug: Cisplatin, docetaxel

Interventions

Cisplatin, Ifosfamide, GemcitabineDRUG

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

A
Ifosfamide, GemcitabineDRUG

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

B
Cisplatin, docetaxelDRUG

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

C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Pneumology department of CHU Lille

Lille, France

Location

Hellenic Cancer Institute - St Savas Oncology Hospital

Athens, Greece

Location

Medical Oncology Hospital de Sagunto

Valencia, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CisplatinIfosfamideGemcitabineDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenes

Study Officials

  • Jean-Paul Sculier, MD, PhD

    European Lung Cancer Working Party

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

February 1, 2004

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

FR(1)ES(1)GR(1)BE(1)