No registrations found.
ID
Source
Brief title
Health condition
Cetuximab, non-small lung carcinoma, cisplation, radiotherapy, locally advanced
Sponsors and support
Intervention
Outcome measures
Primary outcome
The clinical activity of Cetuximab CCRT locally advanced NSCLC (as defined by the objective rate of local control (OLRC)).
Secondary outcome
1. 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.
Background summary
CCRT 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.
Study objective
The addition of the EGFR monoclonal antibody Cetuximab to standaard concurrent chemoradiotherapy improves the outcome of treatment of locally advanced non-small lung carcinoma.
Study design
January 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.
Intervention
Addition 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.
Plesmanlaan 121
M.M. Heuvel, van den
Amsterdam 1066 CX
The Netherlands
+31 (0)20 5122958
m.vd.heuvel@nki.nl
Plesmanlaan 121
M.M. Heuvel, van den
Amsterdam 1066 CX
The Netherlands
+31 (0)20 5122958
m.vd.heuvel@nki.nl
Inclusion criteria
1. >= 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 ¦Ìmol/l or creatinine clearance > 50 ml/min; measured or calculated;
G. Urine dipstick for proteinuria < 1+. If urine dipstick is ¡Ý 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2113 |
| NTR-old | NTR2230 |
| Other | NKI-AVL : M07CCL |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |