A randomised phase III study comparing induction chemotherapy to daily low dose Cisplatin both combined with high dose radiotherapy in patients with inoperable non-small cell lung cancer stage I, II and III

ISRCTN	ISRCTN73271276
DOI	https://doi.org/10.1186/ISRCTN73271276
Protocol serial number	NTR514; M 03 IVC/CKTO 2003-04
Sponsor	Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital (NKI/AVL) and Academic Medical Centre (AMC) (Netherlands)
Funder	Committee for Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A.L.J. Uitterhoeve
Scientific

Academic Medical Center
Department of Radiotherapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5664231
Email	a.l.uitterhoeve@amc.uva.nl

Primary study design	Interventional
Study design	Multicentre randomised open label controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Concurrent chemoradiation is superior to sequential chemoradiation.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Lung cancer
Intervention	Randomisation of sequential versus concurrent chemoradiotherapy
Intervention type	Other
Primary outcome measure(s)	1. Disease-free survival 2. Local control 3. Pattern of recurrence.
Key secondary outcome measure(s)	1. Acute and late toxicity 2. Quality of Life.
Completion date	30/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	100
Key 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%
Key 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
Date of first enrolment	30/05/2003
Date of final enrolment	30/05/2006

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2007		Yes	No