Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
14/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Gore

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PACMAIN

Study information

Scientific title

Acronym

Study hypothesis

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

No ethics information required at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Carboplatin and paclitaxel

Primary outcome measures

Progression-free survival

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/12/2002

Overall trial end date

01/03/2005

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1200

Participant 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

Recruitment start date

16/12/2002

Recruitment end date

01/03/2005

Locations

Countries of recruitment

Australia, United Kingdom

Trial participating centre

Skin & Melanoma Unit
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

The Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Government

Website

http://www.icr.ac.uk

Funders

Funder type

Research organisation

Funder name

The Institute of Cancer Research (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

Publication citations

Additional files

Editorial Notes