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
Protocol serial number	PACMAIN
Sponsor	The Institute of Cancer Research (UK)
Funder	The Institute of Cancer Research (UK)

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

Prof Martin Gore
Scientific

Skin & Melanoma Unit
Royal Marsden NHS Foundation Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Carboplatin and paclitaxel
Primary outcome measure(s)	Progression-free survival
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2005
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Skin & Melanoma Unit

London
SW3 6JJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan