NCT00633568

Brief Summary

The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
4 countries

19 active sites

Status
terminated

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

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

7.9 years

First QC Date

March 5, 2008

Last Update Submit

February 11, 2015

Conditions

Non-small Cell Lung Carcinoma

Keywords

Non-small cell lung carcinomaConcomitant radiochemotherapyCisplatinDocetaxelRadiotherapyChemotherapyUnresectable stage III non-small cell lung carcinoma

Outcome Measures

Primary Outcomes (1)

  • Survival

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

Secondary Outcomes (3)

  • Response rate

    At the end of the whole treatment

  • Toxicity

    After each course of chemotherapy and at the end of treatment

  • Local control rate

    After completion of treatment

Study Arms (2)

A

ACTIVE COMPARATOR

One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy

Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

B

EXPERIMENTAL

Three courses of induction chemotherapy followed by consolidation chemoradiotherapy

Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

Interventions

Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelDRUG

Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1

A
Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelDRUG

Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1

B

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 carcinoma of the lung
  • Initially unresectable non-metastatic stage III disease
  • Availability for participating in the detailed follow-up of the protocol
  • Presence of an evaluable or measurable lesion
  • Written informed consent
  • No functional or anatomical contraindication to chest irradiation

You may not qualify if:

  • Prior treatment with chemotherapy, radiotherapy or surgery
  • Performance status \< 60 on the Karnofsky scale
  • History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
  • Neutrophils \< 2,000/mm³
  • Platelet cells \< 100,000/mm3
  • Serum bilirubin \> 1.5 mg/100 ml
  • Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value
  • Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 60 ml/min
  • Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris
  • Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
  • Uncontrolled infectious disease
  • Symptomatic polyneuropathy
  • Auditive impairment contra-indicating cisplatin administration
  • Serious medical or psychological factors which may prevent adherence to the treatment schedule
  • Malignant pleural or pericardial effusion
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Department of Pneumology RHMS Hôpital de la Madeleine

Ath, 7800, Belgium

Location

Department of Pneumology Clinique Saint-Luc

Bouge, 5004, Belgium

Location

Department of Pneumology CHR St Joseph-Warquignies

Boussu, 7360, Belgium

Location

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Department of Pneumology Hospital Ixelles-Molière

Brussels, Belgium

Location

Department of Pneumology CHU Charleroi

Charleroi, Belgium

Location

Department of Pneumology Hôpital Saint-Joseph

Gilly, 6060, Belgium

Location

Hôpital Ambroise Paré

Mons, 7000, Belgium

Location

Hôpital Vésale - Montigny-le-Tilleul

Montigny-le-Tilleul, 6110, Belgium

Location

Department of Pneumology Centre Hospitalier de Mouscron

Mouscron, 7700, Belgium

Location

CH Peltzer-La Tourelle

Verviers, 4800, Belgium

Location

Service de Pneumologie Centre Hospitalier de Douai

Douai, 59507, France

Location

Service de Pneumologie Hôpital de Hayange

Hayange, 57700, France

Location

Pneumology department of CHU Lille

Lille, France

Location

Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil

Montfermeil, 93370, France

Location

Service de Pneumologie CHG Tourcoing

Tourcoing, 59208, France

Location

Cabinet médical Saint-Michel

Valenciennes, 59300, France

Location

Medical Oncology St Savas Hospital

Athens, 11522, Greece

Location

Medical Oncology Hospital de Sagunto

Valencia, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CisplatinDocetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Thierry Berghmans, MD

    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

March 5, 2008

First Posted

March 12, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

ES(1)BE(11)FR(6)GR(1)