A randomised trial of maintenance weekly paclitaxel versus observation following remission with first-line induction carboplatin and paclitaxel for patients with ovarian cancer
| ISRCTN | ISRCTN48397858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48397858 |
| Secondary identifying numbers | PACMAIN |
- Submission date
- 15/10/2002
- Registration date
- 15/10/2002
- Last edited
- 14/07/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Gore
Scientific
Scientific
Skin & Melanoma Unit
Royal Marsden NHS Foundation Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | It is intended that this study will run in the UK, mainland Europe and Australasia. If the study proves positive, it will require confirmation and will raise the question of whether weekly paclitaxel given for longer periods maybe even more effective. |
| Ethics approval(s) | No ethics information required at time of registration. |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | Maintenance chemotherapy: paclitaxel 70 mg/m^2 weekly, beginning three weeks after the last cycle of carboplatin/paclitaxel induction therapy and continuing for 15 weeks. Updated 11/10/2012: please note that this trial never started due to a lack of funding. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Carboplatin and paclitaxel |
| Primary outcome measure | Progression-free survival |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/12/2002 |
| Completion date | 01/03/2005 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1200 |
| Key inclusion criteria | 1. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer 2. Female, aged 18 years and over 3. International Federation of Gynecology and Obstetrics (FIGO) stage III to IV. Receive six cycles of carboplatin/paclitaxel, three-weekly at registration 4. Able to complete quality of life questionnaires 5. Can comply with follow-up requirements. Written informed consent 6. Response to induction treatment (as demonstrated by a Computed Tomography [CT] scan) |
| Key exclusion criteria | 1. Patients with peritoneal carcinomatosis of 'uncertain' origin which is mucin-secreting 2. Histological evidence of an origin in the gastrointestinal tract, bilary system or lung |
| Date of first enrolment | 16/12/2002 |
| Date of final enrolment | 01/03/2005 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
Study participating centre
Skin & Melanoma Unit
London
SW3 6JJ
United Kingdom
SW3 6JJ
United Kingdom
Sponsor information
The Institute of Cancer Research (UK)
Government
Government
123 Old Brompton Road
London
SW7 3RP
United Kingdom
| Website | http://www.icr.ac.uk |
|---|---|
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Research organisation
The Institute of Cancer Research (UK)
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 |
