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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.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Carcinoma

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Thierry Berghmans, MD

Investigator Role:

Study Chair

Investigator Affiliation:

European Lung Cancer Working Party

Authority:

Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

ELCWP 01063

NCT ID:

NCT00633568

Start Date:

January 2007

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Carcinoma
  • Non-small cell lung carcinoma
  • Concomitant radiochemotherapy
  • Cisplatin
  • Docetaxel
  • Radiotherapy
  • Chemotherapy
  • Unresectable stage III non-small cell lung carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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