Skip to main content
Clinical Trials/EUCTR2006-004726-91-FR
EUCTR2006-004726-91-FR
Active, not recruiting
Phase 1

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

CHRU de Lille0 sites246 target enrollmentMarch 19, 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
nresectable non metastatic stage III non small cell lung carcinoma eligible for concomitant radiochemotherapy
Sponsor
CHRU de Lille
Enrollment
246
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 19, 2009
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHRU de Lille

Eligibility Criteria

Inclusion Criteria

  • \- Men or women aged \= 18 years old
  • \- 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
  • \- Irradiation technically possible
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:

Exclusion Criteria

  • \- Prior treatment with chemotherapy, radiotherapy or surgery
  • \- 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 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

Outcomes

Primary Outcomes

Not specified

Similar Trials