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 |
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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
Scientific
Academic Medical Center
Department of Radiotherapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Phone | +31 (0)20 5664231 |
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a.l.uitterhoeve@amc.uva.nl |
Study information
Study design | Multicentre randomised open label controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 1. Disease-free survival 2. Local control 3. Pattern of recurrence. |
Secondary outcome measures | 1. Acute and late toxicity 2. Quality of Life. |
Overall study start date | 30/05/2003 |
Completion date | 30/05/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital (NKI/AVL) and Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2007 | Yes | No |