Weekly versus three-weekly docetaxel in women with breast cancer
| ISRCTN | ISRCTN09184069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09184069 |
| Secondary identifying numbers | Trial 206(n) protocol 1.0 |
- Submission date
- 25/02/2010
- Registration date
- 02/06/2010
- Last edited
- 29/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Scientific
Research & Development
Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled study of weekly versus three weekly docetaxel in women with breast cancer |
| Study hypothesis | The hypothesis was that weekly docetaxel versus three weekly regime resulted in comparable quality of life without compromising treatment efficacy. |
| Ethics approval(s) | Nottinghamshire Research Ethics Committee, 05/04/2000, ref: 206(n) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Docetaxel |
| Primary outcome measure | 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 study start date | 01/07/2000 |
| Overall study end date | 01/11/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 41 in 2 trial arms (82 in total) |
| 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 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
- England
- United Kingdom
Study participating centre
LN2 5QY
United Kingdom
Sponsor information
Hospital/treatment centre
Greetwell Road
Lincoln
LN2 4AX
England
United Kingdom
| Website | http://www.ulh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/0377kyv52 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/05/2011 | Yes | No |
Editorial Notes
29/01/2016: Plain English summary added.
