Condition category
Cancer
Date applied
25/02/2010
Date assigned
02/06/2010
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Weekly doses of the drug docetaxel have occasionally been used to treat patients with breast cancer. The aim of this study is to compare the effect of weekly versus the standard three-weekly docetaxel treatment on patients’ quality of life.

Who can participate?
Women aged 18 -70 with breast cancer.

What does the study involve?
After 4 cycles of doxorubicin and cyclophosphamide treatment, participants are randomly allocated to receive either 12 cycles of weekly docetaxel or 4 cycles of three-weekly docetaxel.

What are the possible benefits and risks of participating?
Weekly docetaxel may cause fewer side effects and therefore improve patients’ quality of life. The common side effect of chemotherapy is febrile neutropenia (fever).

Where is the study run from?
Lincoln County Hospital (UK)

When is the study starting and how long is it expected to run for?
July 2000 to November 2002

Who is funding the study?
Sanofi Aventis (UK); Royal Thai Army, Bangkok (Thailand); Prince of Songkla University, Songkla (Thailand)

Who is the main contact?
Prof. Oleg Eremin
oleg.eremin@ulh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Oleg Eremin

ORCID ID

Contact details

Research & Development
Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Trial 206(n) protocol 1.0

Study information

Scientific title

A randomised controlled study of weekly versus three weekly docetaxel in women with breast cancer

Acronym

Study hypothesis

The hypothesis was that weekly docetaxel versus three weekly regime resulted in comparable quality of life without compromising treatment efficacy.

Ethics approval

Nottinghamshire Research Ethics Committee, 05/04/2000, ref: 206(n)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary breast cancer

Intervention

Arm A: 12 cycles of weekly docetaxel intravenously (IV) 100 mg/m2 for 12 weeks treatment
Arm B: 4 cycles of three-weekly docetaxel IV 100 mg/m2 for 4 weeks treatment

Follow-up for both arms was 75.5 months.

Intervention type

Drug

Phase

Phase II/III

Drug names

Docetaxel

Primary outcome measures

Quality of life 3 weeks after completion of chemotherapy

Secondary outcome measures

1. Clinical and pathological responses at 12 weeks
2. Disease free survival and overall survival at 5 years

Overall trial start date

01/07/2000

Overall trial end date

01/11/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 - 70 years
2. Unilateral/bilateral large (greater than or equal to 3 cm) or locally advanced primary breast cancer (T3, T4, TxN2), no distant metastases
3. World Health Organization (WHO) performance status of less than 2
4. Adequate cardiac, haematological, renal, and hepatic function

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

41 in 2 trial arms (82 in total)

Participant exclusion criteria

1. Pregnant
2. Previous malignancy (except curatively treated carcinoma in situ of the cervix or basal cell carcinoma of skin)
3. Previous cytotoxic, endocrine, or radiotherapy
4. Active infection
5. Contraindications to corticosteroid administration
6. Pre-existing neurotoxicity (greater than grade 2) as defined by the National Cancer Institute Common Toxicity Criteria (NCI-CTC)
7. Significant cognitive impairment or dementia
8. Inability to complete quality of life (QoL) questionnaires or provide informed consent

Recruitment start date

01/07/2000

Recruitment end date

01/11/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lincoln County Hospital
Lincoln
LN2 5QY
United Kingdom

Sponsor information

Organisation

United Lincolnshire Hospitals NHS Trust (UK)

Sponsor details

Greetwell Road
Lincoln
LN2 4AX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ulh.nhs.uk/

Funders

Funder type

Industry

Funder name

Sanofi-Aventis Pharmaceuticals (UK)

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21592370

Publication citations

  1. Results

    Walker LG, Eremin JM, Aloysius MM, Vassanasiri W, Walker MB, El-Sheemy M, Cowley G, Beer J, Samphao S, Wiseman J, Jibril JA, Valerio D, Clarke DJ, Kamal M, Thorpe GW, Baria K, Eremin O, Effects on quality of life, anti-cancer responses, breast conserving surgery and survival with neoadjuvant docetaxel: a randomised study of sequential weekly versus three-weekly docetaxel following neoadjuvant doxorubicin and cyclophosphamide in women with primary breast cancer., BMC Cancer, 2011, 11, 179, doi: 10.1186/1471-2407-11-179.

Additional files

Editorial Notes

29/01/2016: Plain English summary added.