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
Secondary identifying numbers NTR514; M 03 IVC/CKTO 2003-04
Submission date
09/01/2006
Registration date
09/01/2006
Last edited
12/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.L.J. Uitterhoeve
Scientific

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

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

Study information

Study designMulticentre randomised open label controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesConcurrent chemoradiation is superior to sequential chemoradiation.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedLung cancer
InterventionRandomisation of sequential versus concurrent chemoradiotherapy
Intervention typeOther
Primary outcome measure1. Disease-free survival
2. Local control
3. Pattern of recurrence.
Secondary outcome measures1. Acute and late toxicity
2. Quality of Life.
Overall study start date30/05/2003
Completion date30/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment30/05/2003
Date of final enrolment30/05/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

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

Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

ROR logo https://ror.org/03xqtf034

Funders

Funder type

Research council

Committee for Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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