A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without bolus mitomycin-C in patients with carcinoma of unknown primary origin

ISRCTN ISRCTN63374575
DOI https://doi.org/10.1186/ISRCTN63374575
Secondary identifying numbers RMH E/N 1042
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
30/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designMulticentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration

As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCarcinoma of unknown primary origin
Intervention1. Regimen 1. Protracted Venous Infusion (PVI) 5FU 300 mg/m/day over 24 weeks
2. Regimen 2. PVI 5FU 300 mg/m/day over 24 weeks Mitomycin-C 7 mg/m (total not to exceed 56 mg). Four courses over 24 weeks
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)5-fluorouracil (5FU), mitomycin-C
Primary outcome measureAdded 05/08/09:
1. tumour response
2. survival
3. toxicity
4. quality of life (QoL)
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date30/04/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsFinal recruitment:88 (added 05/08/09)
Key inclusion criteria1. Histological evidence of carcinoma of unknown primary site
2. Patients evaluable for response
3. Must have bi-dimensionally measurable disease as assessed by chest X-ray or Computed Tomography (CT) scan
4. Disease must be outside previously irradiated areas
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment30/04/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

ROR logo "ROR" https://ror.org/0008wzh48

Funders

Funder type

Research organisation

The Royal Marsden NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2003 Yes No