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

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00661011
• Other study ID #: ELCWP 01061
• Status: Terminated
• Phase: Phase 2
• First received: April 15, 2008
• Last updated: February 11, 2015
• Start date: January 2007
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: European Lung Cancer Working Party
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentSpain: Ministry of HealthGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Procedure:
• Lobectomy followed by concomitant mediastinal chemoradiotherapy
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

Locations

Country	Name	City	State
Belgium	Department of Pneumology RHMS Hôpital de la Madeleine	Ath
Belgium	Department of Pneumology CHR St Joseph-Warquignies	Boussu
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
Belgium	Department of Pneumology Hospital Ixelles-Molière	Brussels
Belgium	Department of Pneumology CHU Charleroi	Charleroi
Belgium	Department of Pneumology Hôpital Saint-Joseph	Gilly
Belgium	Hôpital Ambroise Paré	Mons
Belgium	Hôpital Vésale - Montigny-le-Tilleul	Montigny-le-Tilleul
Belgium	Department of Pneumology Centre Hospitalier de Mouscron	Mouscron
Belgium	CH Peltzer-La Tourelle	Verviers
Greece	Medical Oncology St Savas Hospital	Athens
Spain	Medical Oncology Hospital de Sagunto	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Countries where clinical trial is conducted

Belgium,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Survival will be dated from the day of registration until death or last follow up	Yes
Secondary	Operative mortality and morbidity		To be observed during the 30 days following the surgical procedure	Yes
Secondary	Local control rate		After completion of treatment	No
Secondary	Toxicity		After each course of chemotherapy and at the end of treatment	No

External Links

•   (Click here for more information on the protocol)