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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661011

Enrollment

Registered

2008-04-18

Start date

2007-01-31

Completion date

2014-06-30

Last updated

2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDURELobectomy 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Belgium, Greece, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026