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NEDERLANDS





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van CCT (UK)


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van CCT (UK)


A randomized 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.


- candidate number1801
- NTR NumberNTR514
- ISRCTNISRCTN73271276
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR1-nov-2005
- Secondary IDsM 03 IVC/ CKTO 2003-04 
- Public TitleA randomized 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.
- Scientific TitleA randomized 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.
- ACRONYMN/A
- hypothesisConcurrent chemoradiation is superior to sequential chemoradiation.
- Healt Condition(s) or Problem(s) studiedLung cancer
- Inclusion criteria1. Pathologically confirmed Non-small cell lung cancer;
2. Medically inoperable or irresectable NSCLC T 1-4, N0-3, M0;
3. Age >18 yr;
4. Weight loss < 10% in the last 3 months;
5. FeV1>0.99l, TLCO> 59%.
- 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. Creatinin clearance <70 ml/min or creatinin > 1.25 x normal value;
10. Bone marrow hypoplasia(Hb,6.8mmol/l, WBC,4x10 9 /l, platelets,100x10 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 50Gy;
13. Impossibility to exclude 2/3 of the heart from the boost volume.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-mei-2003
- planned closingdate30-mei-2006
- Target number of participants100
- InterventionsRandomisation of sequential versus concurrent chemoradiotherapy.
- Primary outcomeDisease-free survival, local control, pattern of recurrence.
- Secondary outcomeAcute and late toxicity, Quality of Life.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES A.L.J. Uitterhoeve
- CONTACT for SCIENTIFIC QUERIES J. Belderbos
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL), Department of Radiotherapy, Academic Medical Center (AMC), Department of Radiotherapy
- Funding
(Source(s) of Monetary or Material Support)
CKTO
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD1-nov-2005 - 18-nov-2008


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