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Onderzoek naar de werkzaamheid van toevoeging van Cetuximab aan de combinatie van radiotherapie en Cisplatin bij patiŽnten met niet-kleincellig longkanker.


- candidate number7779
- NTR NumberNTR2230
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-feb-2010
- Secondary IDsM07CCL NKI-AVL
- Public TitleOnderzoek naar de werkzaamheid van toevoeging van Cetuximab aan de combinatie van radiotherapie en Cisplatin bij patiŽnten met niet-kleincellig longkanker.
- Scientific TitleOpen-label, randomized, multi-center study investigating Cetuximab, in combination with concurrent chemo- / radiotherapy in locally advanced non-small cell lung carcinoma.
- ACRONYMRADITUX
- hypothesisThe addition of the EGFR monoclonal antibody Cetuximab to standaard concurrent chemoradiotherapy improves the outcome of treatment of locally advanced non-small lung carcinoma.
- Healt Condition(s) or Problem(s) studiedRadiotherapy, Non small cell lung cancer (NSCLC), Cisplatin, Cetuximab, Locally advanced
- Inclusion criteria1. >= 18 years of age;
2. Histologically or cytologically confirmed diagnosis of NSCLC;
3. Stage II/III non-operable disease, without malignant pleural effusion;
4. Presence of at least one measurable target lesion;
5. Acceptable pulmonary function as defined by a Fev1 of >=30% and a DLCO of > 40% of predicted;
6. WHO performance 0-1;
7. Life expectancy of at least 6 months;
8. Adequate haematological, renal and hepatic functions:
A. Absolute neutrophil count > 2x109/l;
B. Platelet count > 100 x 109/l;
C. Total bilirubin < 2 x UNL;
D. ASAT/ALAT < 3 x UNL;
E. Alkaline phosphatase < 5 x UNL;
F. Creatinine < 130 ¶Őmol/l or creatinine clearance > 50 ml/min; measured or calculated;
G. Urine dipstick for proteinuria < 1+. If urine dipstick is °› 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.
9. No pre-existing sensory neurotoxicity grade >= 2 (CTC);
10. Patients of reproductive potential must agree to practice an effective medically approved contraceptive method during the trial and 3 months afterwards;
11. Expected risk of radiation-induced pulmonary toxicity is not high: V20 =< 36% / MLD =< 20%;
12. Signed written informed consent.
- Exclusion criteria1. Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 5 years or more before study entry and the patient has remained disease free);
2. Prior:
A. Ipsilateral radiotherapy to the chest;
B. Chemotherapy within the last 5 years;
C. Immunotherapy or treatment with murine monoclonal antibodies, Cetuximab, or other EGFR inhibitors.
3. Pregnant or breast-feeding patients;
4. WHO performance score > 1;
5. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension;
6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial;
7. Participation in other trial with investigational drug or treatment modality.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-feb-2008
- planned closingdate31-dec-2010
- Target number of participants110
- InterventionsAddition of Cetuximab to standard concurrent chemoradiotherapy (CCRT). Standard CCRT consists of Daily dosing of Cisplatin (6mg/m2) and radiotherapy (2.75Gy) during 24 consecutive days excluding the weekends. Cetuximab is given at a loading dose of 400mg/m2 one week prior to the start of CCRT and is then given at a weekly dose of 250mg/m2 during 5 weeks concomitantly to the CCRT.
- Primary outcomeThe clinical activity of Cetuximab CCRT locally advanced NSCLC (as defined by the objective rate of local control (OLRC)).
- Secondary outcome1. The safety profile of Cetuximab in combination with concurrent chemo-radiotherapy;
2. Overall survival (OS);
3. Progression free survival (locoregional/distant) (PFS);
4. Duration of overall response;
5. Response duration;
6. Adverse events.
- TimepointsJanuary 2008: Start feasibility study. Three months after closure of feasibility phase the second phase will start.
Last patient: January 2010.
Follow-up duration: Twelve months or until disease progression.
- Trial web siteTRION, MKI-AVL
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.M. Heuvel, van den
- CONTACT for SCIENTIFIC QUERIESDr. M.M. Heuvel, van den
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
MerckSerono
- PublicationsN/A
- Brief summaryCCRT is the treatment of choice for patients with locally advanced NSCLC. To improve outcome this trial will combine standard CCRT with the EGFR-monoclonal antibody Cetuximab, that has shown promissing results in both advanced NSCLC and in combination with radiotherapy in Head and Neck cancer. This trial is designed as a two steps study with a feasibility part and a randomized phase II study comparing CCRT with CCRT plus Cetuximab.
- Main changes (audit trail)
- RECORD19-feb-2010 - 5-mrt-2010


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