Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201207000396219 Date of Approval: 19/07/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adjuvant topical 5fluorouracil (5FU) for ocular surface squamous neoplasia
Official scientific title A double-masked randomised placebo-controlled trial of adjuvant topical 5-fluorouracil (5FU) treatment following surgical excision of ocular surface squamous neoplasia.
Brief summary describing the background and objectives of the trial In the tropics, ocular surface squamous neoplasia (OSSN) is a relatively common aggressive disease affecting younger adults. Treatment usually involves surgical excision, however, recurrence is quite common. A Cochrane review shows there have been no randomised controlled trials of the various treatment alternatives in practice. We aim To determine whether the 1-year risk of recurrence of OSSN can be reduced through the use of adjuvant 5-fluorouracil eyedrops.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ocular surface squamous neoplasia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/08/2012
Actual trial start date 23/08/2012
Anticipated date of last follow up 30/06/2014
Actual Last follow-up date 14/05/2015
Anticipated target sample size (number of participants) 504
Actual target sample size (number of participants) 98
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ECCT/12/04/01 Kenya Pharmacy and Poisons Board
6097 London School of Hygiene & Tropical Medicine Interventions Research Ethics Committee
P459/11/2011 Kenyatta National Hospital Ethics & Research Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by STATA software Numbered eyedrop bottles Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Artificial tears 2 drops applied 4 times daily 30 days 0.7% Hydroxypropyl methylcellulose 49
Experimental Group 5FU 2 drops applied 4 times daily 30 days 1% 5-fluorouracil eyedrops in 0.7% Hydroxypropyl Methylcellulose 49 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) Histologically proven ocular surface squamous neoplasia (OSSN) (ii) attended for post-operative follow-up within the first two months of excision (iii) Healed excision site. (iv) At least 18 years of age. (i) Prior treatment with topical or subconjunctival antimetabolite drugs such as 5FU, Mitomycin C (MMC) to the same eye or systemic cytotoxic drugs. (ii) Patients who may need more radical surgery than a simple excision eg. features suggestive of metastasis. (iii) Pregnant or breastfeeding mothers. 18 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2012 Kenyatta National Hospital Ethics & Research Committee
Ethics Committee Address
Street address City Postal code Country
Ngong Road Nairobi 00202 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/02/2012 London School of Hygiene & Tropical Medicine Interventions Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Development of a clinical recurrence of the lesion at any time during the first year of follow-up, confirmed by histology where this was available month 1 month 3 month 6 month 12
Secondary Outcome Adverse effects of using topical 5-FU 1% four times daily for one month. month 1 month 3 month 6 month 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
PCEA Kikuyu Hospital Eye Unit Kikuyu Rd Kikuyu - Kenya
Sabatia Eye Hospital Wondaga 50311 Kenya
Kitale District Hospital Trans Nzoia Kitale 30200 Kenya
Kenyatta National Hospital Eye clinic Ngong Road Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
British Council for Prevention of Blindness (BCPB) 4 Bloomsbury Square London WC1A 2RP United Kingdom
The Wellcome Trust Gibbs Building, 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Nairobi Ngong Rd Nairobi 00202 United Kingdom
University College London (UCL) Institute of Ophthalmology 11-43 Bath Street London EC1V 9EL United Kingdom
Kenyatta National Hospital Ngong Rd Nairobi 00202 Kenya
PCEA Kikuyu Hospital Kikuyu Rd Kikuyu - Kenya
Sabatia Eye Hospital PO Box 214 Wodanga 50311 Kenya
Kitale District Hospital PO Box 98 Kitale 30200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Gichuhi sgichuhi@uonbi.ac.ke +2540-722873059 P.O Box 347
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior Lecturer & Consultant Ophthalmologist
Role Name Email Phone Street address
Public Enquiries Stephen Gichuhi sgichuhi@uonbi.ac.ke +2540-722873059 PO Box 347
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior Lecturer & Consultant Ophthalmologist
Role Name Email Phone Street address
Scientific Enquiries Stephen Gichuhi sgichuhi@uonbi.ac.ke +2540-722873059 PO Box 347
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior Lecturer & Consultant Ophthalmologist
REPORTING
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