search
Back to results

Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and 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 Non-small Cell Lung Carcinoma focused on measuring Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Docetaxel, Radiotherapy, Chemotherapy, Unresectable stage III 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 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

Exclusion Criteria:

  • 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
  • Homolateral supraclavicular lymph node excepting upper lobe lesion
  • Heterolateral supraclavicular lymph node
  • Known hypersensitivity to docetaxel or cisplatin
  • Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method

Sites / Locations

  • Department of Pneumology RHMS Hôpital de la Madeleine
  • Department of Pneumology Clinique Saint-Luc
  • Department of Pneumology CHR St Joseph-Warquignies
  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
  • Department of Pneumology Hospital Ixelles-Molière
  • Department of Pneumology CHU Charleroi
  • Department of Pneumology Hôpital Saint-Joseph
  • Hôpital Ambroise Paré
  • Hôpital Vésale - Montigny-le-Tilleul
  • Department of Pneumology Centre Hospitalier de Mouscron
  • CH Peltzer-La Tourelle
  • Service de Pneumologie Centre Hospitalier de Douai
  • Service de Pneumologie Hôpital de Hayange
  • Pneumology department of CHU Lille
  • Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
  • Service de Pneumologie CHG Tourcoing
  • Cabinet médical Saint-Michel
  • Medical Oncology St Savas Hospital
  • Medical Oncology Hospital de Sagunto

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

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

Three courses of induction chemotherapy followed by consolidation chemoradiotherapy

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Response rate
Toxicity
Local control rate

Full Information

First Posted
March 5, 2008
Last Updated
February 11, 2015
Sponsor
European Lung Cancer Working Party
search

1. Study Identification

Unique Protocol Identification Number
NCT00633568
Brief Title
Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
Official Title
A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Carcinoma
Keywords
Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Docetaxel, Radiotherapy, Chemotherapy, Unresectable stage III 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
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy
Arm Title
B
Arm Type
Experimental
Arm Description
Three courses of induction chemotherapy followed by consolidation chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
Intervention Description
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
Primary Outcome Measure Information:
Title
Survival
Time Frame
Survival will be dated from the day of randomisation until death or last follow up
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
At the end of the whole treatment
Title
Toxicity
Time Frame
After each course of chemotherapy and at the end of treatment
Title
Local control rate
Time Frame
After completion of treatment

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 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 Exclusion Criteria: 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 Homolateral supraclavicular lymph node excepting upper lobe lesion Heterolateral supraclavicular lymph node Known hypersensitivity to docetaxel or cisplatin Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Berghmans, MD
Organizational Affiliation
European Lung Cancer Working Party
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pneumology RHMS Hôpital de la Madeleine
City
Ath
ZIP/Postal Code
7800
Country
Belgium
Facility Name
Department of Pneumology Clinique Saint-Luc
City
Bouge
ZIP/Postal Code
5004
Country
Belgium
Facility Name
Department of Pneumology CHR St Joseph-Warquignies
City
Boussu
ZIP/Postal Code
7360
Country
Belgium
Facility Name
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Department of Pneumology Hospital Ixelles-Molière
City
Brussels
Country
Belgium
Facility Name
Department of Pneumology CHU Charleroi
City
Charleroi
Country
Belgium
Facility Name
Department of Pneumology Hôpital Saint-Joseph
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Hôpital Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Hôpital Vésale - Montigny-le-Tilleul
City
Montigny-le-Tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Department of Pneumology Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
CH Peltzer-La Tourelle
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Facility Name
Service de Pneumologie Centre Hospitalier de Douai
City
Douai
ZIP/Postal Code
59507
Country
France
Facility Name
Service de Pneumologie Hôpital de Hayange
City
Hayange
ZIP/Postal Code
57700
Country
France
Facility Name
Pneumology department of CHU Lille
City
Lille
Country
France
Facility Name
Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Service de Pneumologie CHG Tourcoing
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Cabinet médical Saint-Michel
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
Medical Oncology St Savas Hospital
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
Medical Oncology Hospital de Sagunto
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer

We'll reach out to this number within 24 hrs