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A Phase II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Carcinoma

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Trial Information

A Phase II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy


Inclusion Criteria:



- Histological or cytological diagnosis of non-small cell carcinoma of the lung

- Initially stage III NSCLC

- Pathologically proven N2 or N3 disease

- Any response to induction chemotherapy (whatever the regimen administered)

- Disease still not fully resectable (because of extensive mediastinal N disease) and
not suitable for radical radiotherapy (single field) after induction chemotherapy

- Lobectomy possible for the treatment of T disease

- Availability for participating in the detailed follow-up of the protocol

- Informed consent

Exclusion Criteria:

- Prior treatment with radiotherapy or surgery

- Karnofsky PS < 60

- Functional or anatomical contra-indication to mediastinal radiotherapy

- Functional or anatomical contra-indication to surgical lobectomy

- 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)

- Malignant pleural or pericardial effusion

- Neutrophils < 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

- Recent myocardial infarction (less than 3 months prior to date of diagnosis)

- Congestive cardiac failure or cardiac arrhythmia requiring medical treatment

- Uncontrolled infectious disease

- Hearing loss

- Symptomatic polyneuropathy

- Serious medical or psychological factors which may prevent adherence to the treatment
schedule

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Jean-Paul Sculier, MD, PhD

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 01061

NCT ID:

NCT00661011

Start Date:

January 2007

Completion Date:

June 2014

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Non-small cell lung carcinoma
  • Concomitant radiochemotherapy
  • Cisplatin
  • Vinorelbine
  • Radiotherapy
  • Chemotherapy
  • Unresectable stage III non-small cell lung carcinoma
  • Surgery
  • Unresectable stage III non-small cell lung carcinoma not suitable for radical radiotherapy after objective response to induction chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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