Establish the safety and feasibility of sequential chemotherapy and SRT.
ID
Bron
Verkorte titel
Aandoening
non-small-cell lung cancer. longkanker
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety and feasibility of sequential chemotherapy and SRT.
Achtergrond van het onderzoek
Phase I study on safety and feasibility of cisplatin-pemetrexed administered before or after SRT in stage IB NSCLC. A total of 20 patients with inoperable stage IB NSCLC, or patients with stage IB NSCLC refusing surgery, who would receive SRT monotherapy as standard treatment outside the study, will be included.
Doel van het onderzoek
Establish the safety and feasibility of sequential chemotherapy and SRT.
Onderzoeksopzet
Patients participating in this study will be administered intravenously 3 courses (1 course = 3 weeks) of cisplatin/pemetrexed, before or after SRT. Hospitalization length is 3 days for 1 course. After the treatment, checkups are weekly for the first 4 weeks, then at 3 months, 6 months, 1 year to 5 year.
Onderzoeksproduct en/of interventie
In the first 10 patients, 3 cycles of cisplatin-pemetrexed will be administered after SRT; In the second arm, 3 identical cycles of chemotherapy will be administered preceding SRT treatment.
Publiek
VU University Medical Centre<br>
PO Box 7057
E.F. Smit
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444782
ef.smit@vumc.nl
Wetenschappelijk
VU University Medical Centre<br>
PO Box 7057
E.F. Smit
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444782
ef.smit@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Any histologically or cytologically proven NSCLC;
2. Stage IB NSCLC (T2N0M0);
3. FDG-PET scan consistent with stage IB NSCLC;
4. Age 18 years or older;
5. Patients should be fit to undergo chemotherapy and be eligible for SRT using 5 or 8 fractions as specified;
6. Adequate organ function;
7. Signed informed consent;
8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnant or lactating women;
2. Concomitant treatment with any other experimental drug under investigation;
3. Inability or unwillingness to take folic acid or vitamin B-12 supplementation;
4. Diagnosis of a synchronous second malignancy;
5. Small-Cell Lung cancer (SCLC) or a mixed SCLC-NSCLC;
6. Prior thoracic radiotherapy;
7. Prior systemic anti-cancer chemotherapy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1714 |
| NTR-old | NTR1824 |
| Ander register | 2008-004731-37 : 2008/251 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |