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An international randomized trial in Locally Advanced Breast Cancer comparing 6 courses of neo-adjuvant doxorubicin and cyclophosphamide plus GM-CSF or G-CSF with a split-course administration of 3 neo-adjuvant and 3 adjuvant cycles including either GM-CSF or G-CSF.


- candidate number1289
- NTR NumberNTR170
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsN/A 
- Public TitleAn international randomized trial in Locally Advanced Breast Cancer comparing 6 courses of neo-adjuvant doxorubicin and cyclophosphamide plus GM-CSF or G-CSF with a split-course administration of 3 neo-adjuvant and 3 adjuvant cycles including either GM-CSF or G-CSF.
- Scientific TitleAn international randomized trial in Locally Advanced Breast Cancer comparing 6 courses of neo-adjuvant doxorubicin and cyclophosphamide plus GM-CSF or G-CSF with a split-course administration of 3 neo-adjuvant and 3 adjuvant cycles including either GM-CSF or G-CSF.
- ACRONYMSpinoza
- hypothesisTo detect any effect on disease-free survival from treatment with 3 neo-adjuvant and 3 adjuvant chemotherapy cycles (standard treatment) versus 6 neo-adjuvant chemotherapy cycles To study the effect of GM-CSF versus G-CSF on potential effect on disease-free survival.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1. Histologically proven breast cancer;
2. Locally advanced breast cancer: stage IIB with a primary breast tumor > 5 cm (T3 tumor), IIIA or IIIB according to the AJCC criteria;
3. Adequate hematological, renal and hepatic functions (WBC 3.0 x 109/l, platelets 150 x 109/l); normal serum bilirubin; normal ASAT (SGOT), ALAT (SGPT) and AF, normal serum creatinine;
4. Age > 18 and < 65 years;
5. Performance status (Karnofsky index 80% or WHO grade 1);
6. Written informed consent.
- Exclusion criteria1. Pregnant, or lactating patients. Patients of childbearing potential must use adequate contraception;
2. Distant metastases;
3. Clinically evident infection or other serious underlying medical condition not compatible with studies entry, eg. Uncontrolled hypertension, cardiac disease (ischaemia, previous myocardial infarction) within 6 months prior to treatment; 4. LVEF < 50%;
5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent;
6. Prior history of malignancy other than adequately treated basal cell carcinoma of the skin or in sity carcinoma of the cervix, or current other malignancy;
7. Bilateral breast cancer;
8. Previous chemotherapy, radiotherapy or hormone therapy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-1999
- planned closingdate1-jun-2005
- Target number of participants720
- InterventionsArm A:
6 neoadjuvant cycles doxorubicin and cyclophosphamide;
Arm B:
3 neoadjuvant + 3 adjuvant cycles doxorubicin and cyclophosphamideIn each study arm 50% of the patients will receive GM-CSF(250 g/m2 daily sc day 2-12) and 50% G-CSF (5 g/kg daily sc day 2-12) in a randomised fashion. Doxorubicin and cyclophosphamide are administered on day 1 every 3 weeks.
Doses of doxorubicin :

Cycle 1 90 mg/m2;
Cycles 2-3 82.5 mg/m2;
Cycles 4-C6 75 mg/m2
Doses of cyclophosphamide:
Cycle 1 1000 mg/m2;
Cycles 2-3 875 mg/m2;
Cycles 4-6 750 mg/m2
- Primary outcomeRecurrence of disease or all cause mortality (whichever comes first).
- Secondary outcome1. Disease-free survival;
2. Overall survival;
3. Response rate.
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESProf. Dr. H.M. Pinedo
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.M. Pinedo
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryThe study has ceased due to a stop of procedure GM-CSF by the manufacturer.

De studie is gestaakt vanwege stop procedure GM-CSF door de fabrikant.
- Main changes (audit trail)
- RECORD24-aug-2005 - 20-mei-2008


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