Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy

NCT00661011 | Terminated Phase 2 DMC

• 1 other identifier: ELCWP 01061
• Study Type: interventional
• Target: 75
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy.

Conditions

Non Small Cell Lung Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival

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

Secondary Outcomes (3)

• Operative mortality and morbidity

  To be observed during the 30 days following the surgical procedure

• Local control rate

  After completion of treatment

• Toxicity

  After each course of chemotherapy and at the end of treatment

Study Arms (1)

A

EXPERIMENTAL

Lobectomy followed by mediastinal concomitant chemoradiotherapy

Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy

Interventions

Lobectomy followed by concomitant mediastinal chemoradiotherapy PROCEDURE

Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Lung Cancer Working Party: lead

Study Sites (12)

Department of Pneumology RHMS Hôpital de la Madeleine

Ath, 7800, 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, 6000, 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

Medical Oncology St Savas Hospital

Athens, 11522, Greece

Location

Medical Oncology Hospital de Sagunto

Valencia, Spain

Location

Related Links

• (Click here for more information on the protocol)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Paul Sculier, MD, PhD

  European Lung Cancer Working Party

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

BE (10); GR (1); ES (1)