search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A phase 1 study with cisplatin and pemetrexed administered before or after stereotactic radiotherapy (SRT) in patients with stage IB non-small-cell lung cancer (NSCLC).


- candidate number5779
- NTR NumberNTR1824
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-mei-2009
- Secondary IDs2008/251 2008-004731-37
- Public TitleA phase 1 study with cisplatin and pemetrexed administered before or after stereotactic radiotherapy (SRT) in patients with stage IB non-small-cell lung cancer (NSCLC).
- Scientific TitleA 2-step phase I study evaluating the safety of (neo-)adjuvant cisplatin-pemetrexed and stereotactic radiotherapy (SRT) for patients with stage IB non-small-cell lung cancer (NSCLC).
- ACRONYMCisplatin-pemetrexed and SRT in stage IB NSCLC
- hypothesisEstablish the safety and feasibility of sequential chemotherapy and SRT.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-feb-2011
- Target number of participants20
- InterventionsIn 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.
- Primary outcomeSafety and feasibility of sequential chemotherapy and SRT.
- Secondary outcomeLocal control, disease progression and quality of life.
- TimepointsPatients 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. MD. PhD. E.F. Smit
- CONTACT for SCIENTIFIC QUERIESProf. Dr. MD. PhD. E.F. Smit
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Eli Lilly Nederland B.V.
- PublicationsN/A
- Brief summaryPhase 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.
- Main changes (audit trail)
- RECORD19-mei-2009 - 30-sep-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl