Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C93

Study information

Scientific title

A multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer

Acronym

Study hypothesis

Added 06/08/2009:
To determine the impact of intensive induction chemotherapy plus g-csf in comparison to a standard regimen on time to distant metastases and overall survival in patients with locally advanced or inflammatory breast cancer.

As of 06/08/2009 this trial has been updated. All updates can be found under the relevant field with the above update date.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

1. Regimen A: Chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) repeated every four weeks for six courses, unless there is earlier progression, plus oral trimethoprim-sulphamethoxazole (TMP + SMZ) 480 mg twice daily for the duration of chemotherapy.

2. Regimen B: High dose intensity chemotherapy with etoposide and cyclophosphamide plus Granulocyte-Colony Stimulating Factor (G-CSF) repeated every two weeks for six cycles, unless there is earlier progression. If following chemotherapy there is a response or stable disease then patients commence locoregional treatment, either surgery, radiotherapy or both. Following locoregional treatment patients receive maintenance hormonotherapy, tamoxifen 20 mg daily until relapse.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cyclophosphamide, epirubicin, 5-fluorouracil, etoposide, granulocyte-colony stimulating factor (G-CSF), trimethoprim-sulphamethoxazole and tamoxifen

Primary outcome measures

Added 06/08/2009:
1. Response rate
2. Survival
3. Quality of life

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

04/04/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients with histologically confirmed breast cancer in the following subgroups:
1.1. T4 Nx
1.2. Any N2 or N3, M0
1.3. Clinically inflammatory breast carcinoma defined as redness over at least one-third of the breast
1.4. M0 except for ipsilateral supraclavicular nodes
2. No evidence of tumour spread other than as defined above
3. No previous surgical, systemic or radiation treatment for breast cancer, other than biopsy for confirmation of the diagnosis
4. World Health Organisation (WHO) performance status zero to two
5. Adequate renal, hepatic and haematological function
6. No previous or concomitant malignancy except adequately treated squamous or basal cell carcinoma of the skin, or adequately treated cone-biopsied in situ carcinoma of the cervix uteri
7. No significant cardiac disease

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400 (added 06/08/2009)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/1996

Recruitment end date

04/04/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Sponsor details

83
Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium
+32 (0)2 774 16 41
eortc@eortc.be

Sponsor type

Research organisation

Website

http://www.eortc.be

Funders

Funder type

Research organisation

Funder name

European Organisation for Research and Treatment of Cancer

Alternative name(s)

EORTC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Belgium

Funder name

National Cancer Institute of Canada (NCIC) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss Institute for Applied Cancer Research (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes