Contact information
Type
Scientific
Primary contact
Dr A.L.J. Uitterhoeve
ORCID ID
Contact details
Academic Medical Center
Department of Radiotherapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5664231
a.l.uitterhoeve@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR514; M 03 IVC/CKTO 2003-04
Study information
Scientific title
Acronym
Study hypothesis
Concurrent chemoradiation is superior to sequential chemoradiation.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lung cancer
Intervention
Randomisation of sequential versus concurrent chemoradiotherapy
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
1. Disease-free survival
2. Local control
3. Pattern of recurrence.
Secondary outcome measures
1. Acute and late toxicity
2. Quality of Life.
Overall trial start date
30/05/2003
Overall trial end date
30/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pathologically confirmed non-small cell lung cancer (NSCLC)
2. Medically inoperable or irresectable NSCLC T 1-4, N0-3, M0
3. Age >18 years
4. Weight loss <10% in the last 3 months
5. FeV1 >0.99l, TLCO >59%
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Previous chemotherapy and/or radiotherapy of the chest
2. Superior Vena cava syndrome
3. Hemoptysis causing a decrease of the blood haemoglobin of >1 mmol/l within 24 hours
4. Pleural or pericardial effusion (except if negative cytology)
5. Uncontrolled infection
6. Maximal length of the esophagus receiving 40 Gy of more than 18 cm, or maximal length of the esophagus receiving 66 Gy of more than 12 cm
7. Serious medical risk factors involving any of the major organ systems which may prevent adherence to the treatment schedule
8. Patients with pre-existant fibrotic lung disease
9. Creatinine clearance <70 ml/min or creatinine >1.25 x normal value
10. Bone marrow hypoplasia (Hb 6.8 mmol/l, WBC 4 x 10^9/l, platelets 100 x 10^9/l)
11. Recent myocardial infarction(<6 months) or evidence of heart failure
12. Impossibility to limit the spinal cord dose to a maximum of 50 Gy
13. Impossibility to exclude 2/3 of the heart from the boost volume
Recruitment start date
30/05/2003
Recruitment end date
30/05/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Research council
Funder name
Committee for Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17084621
Publication citations
-
Results
Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C, , Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973)., Eur. J. Cancer, 2007, 43, 1, 114-121, doi: 10.1016/j.ejca.2006.09.005.