Clinical trial NCT00661011: Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: Survival will be dated from the day of registration until death or last follow up
Secondary outcomes:
measure: Operative mortality and morbidity
timeFrame: To be observed during the 30 days following the surgical procedure
measure: Local control rate
timeFrame: After completion of treatment
measure: Toxicity
timeFrame: After each course of chemotherapy and at the end of treatment
Other outcomes:
Locations:
city: Ath
country: Belgium
facility: Department of Pneumology RHMS Hôpital de la Madeleine
city: Boussu
country: Belgium
facility: Department of Pneumology CHR St Joseph-Warquignies
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Brussels
country: Belgium
facility: Department of Pneumology Hospital Ixelles-Molière
city: Charleroi
country: Belgium
facility: Department of Pneumology CHU Charleroi
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Montigny-le-Tilleul
country: Belgium
facility: Hôpital Vésale - Montigny-le-Tilleul
city: Mouscron
country: Belgium
facility: Department of Pneumology Centre Hospitalier de Mouscron
city: Verviers
country: Belgium
facility: CH Peltzer-La Tourelle
city: Athens
country: Greece
facility: Medical Oncology St Savas Hospital
city: Valencia
country: Spain
facility: Medical Oncology Hospital de Sagunto
Study officials:
affiliation: European Lung Cancer Working Party
name: Jean-Paul Sculier, MD, PhD
role: STUDY_CHAIR
References: