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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN62673495 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective randomised evaluation of high-intensity chemotherapy with peripheral blood progenitor support in patients with high risk breast cancer
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Scientific title:
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Prospective randomised evaluation of high-intensity chemotherapy with peripheral blood progenitor support in patients with high risk breast cancer |
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Date of first enrolment:
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01/01/1997 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN62673495 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged >18 years (usually <55 years).
2. Histologically proven operable stage II or IIIA breast cancer with an involvement of at least four lymph nodes
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Confirmed normal haematological and biochemical parameters
5. Free from overt metastatic disease
6. No other malignancy, except basal cell carcinoma of the skin or in-situ carcinoma of the cervix
7. Fit to receive treatment
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Breast cancer
Cancer
Breast cancer
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Intervention(s)
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1. High Dose Arm: Induction chemotherapy with single agent doxorubicin (adriamycin), treatment to be repeated every 3 weeks for four cycles. Induction chemotherapy to be followed by high dose chemotherapy, cyclophosphamide then cyclophosphamide and thiotepa, with stem cell support.
2. Conventional Arm: Induction chemotherapy with single agent doxorubicin, treatment to be repeated every 3 weeks for four cycles followed by conventional cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight cycles.
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Amgen (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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