A Randomised Study of Observation versus Adjuvant Low Dose Extended Duration Interferon Alpha-2a in High Risk Resected Malignant Melanoma

ISRCTN	ISRCTN13456221
DOI	https://doi.org/10.1186/ISRCTN13456221
Secondary identifying numbers	AIM HIGH

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Skin cancer
Intervention	Patients are randomised to one of two treatment arms: 1. Arm A: Interferon alpha-2a 3MU three times per week until recurrence, or for 2 years. 2. Arm B: No further treatment.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Interferon Alpha-2a
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2000
Completion date	22/12/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	674
Key inclusion criteria	1. Patients with histologically proven malignant melanoma and high risk of recurrent metastatic disease will be eligible for the present study. This will include patients with either: a. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at initial presentation b. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at subsequent presentation c. Non-nodal superficial regional recurrence (local or in-transit disease) d. Primary tumours 4 mm or more Breslow thickness without any other detectable focus of metastasis 2. Fit to receive interferon 3. Wound healed following surgery 4. Clinically disease-free 5. No history of other malignant disease, except previously cured early carcinoma of the cervix or skin 6. No previous biological therapy 7. Not on systemic steroids or other immunosuppressive therapy 8. Not pregnant, lactating or intending pregnancy during treatment 9. Less than 12 weeks since resection
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	22/12/2000

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Roche Products Limited (UK)
Industry

P.O. Box 8
Welwyn Garden City, Hertfordshire
AL7 3AY
United Kingdom

Website	http://www.roche.com
"ROR"	https://ror.org/024tgbv41

Industry

Roche Products Ltd

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2004		Yes	No