Determination of the predictive value of FDG-PET-CT scans, blood proteins and blood cells for the prognosis for patients with lung cancer receiving concurrent chemo-radiatio

Phase 3

Conditions: lungcancer
10029107

Registration Number: NL-OMON31446

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Histological or cytological proven non-small cell or small cell lung cancer. Mixed histologies (NSCLC and SCLC) are allowed;
UICC stage I-III (in case of small cell lung cancer: limited stage);
WHO performance status 0-2;
Less than 10 % weight loss the last 6 months;
In case of previous chemotherapy, concurrent chemo-radiotherapy can start after a minimum of 21 days after the last chemotherapy course;
No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction);
No active peptic oesophagitis;
Life expectancy more than 6 months;
Measurable cancer;
Willing and able to comply with the study prescriptions;
18 years or older;
Not pregnant and willing to take adequate contraceptive measures during the study;
Have given written informed consent before patient registration ;
No previous radiotherapy to the chest.

Exclusion Criteria

Not non-small cell or small cell histology, e.g. mesothelioma, lymphoma
Malignant pleural or pericardial effusion
History of prior chest radiotherapy
Recent (< 3 months) myocardial infarction
Uncontrolled infectious disease
Distant metastases (stage IV)
Patients with active peptic oesophagitis in the last year
Less than 18 years old
Pregnant or not willing to take adequate contraceptive measures during the study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tumour response, measured with FDG-PET-CT scans 3 months post-radiation, as a<br /><br>function of delta FDG uptafe the first week during radiotherapy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Incidence of acute radiation-induced oesophagitis<br /><br>- Incidence of radiation-induced pulmonary toxicity 3 and 9 months<br /><br>post-radiotherapy</p><br>