Condition category
Cancer
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
12/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital (NKI/AVL) and Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17084621

Publication citations

  1. 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.

Additional files

Editorial Notes