|
ISRCTN
|
ISRCTN49221770
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Randomised Study of MVP (Mitomycin-C, Vinblastine and Moderate Dose Cisplatin) Three versus Six Cycles in Advanced Non-Small Cell Lung Cancer
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
L14
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Lung (non-small cell) cancer
|
|
Participants - inclusion criteria
|
1. Histological evidence of non-small cell lung cancer
2. Stage IIIb or IV disease not eligible for neoadjuvant chemotherapy and/or radical radiotherapy
3. Performance status <2 (Zubrod-Eastern Cooperative Oncology Group [ECOG]-World Health Organisation [WHO] scale)
4. Adequate renal, bone marrow, and lung function tests unless due to metastatic disease
5. Patients must already have achieved symptom relief after three cycles of MVP chemotherapy
6. No uncontrolled infection
7. No previous conventional chemotherapy prior to MVP. One prior phase I/II new drug is allowed
8. No medical contraindications to treatment protocols
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2000
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
All patients receive chemotherapy with MVP (mitomycin-C, vinblastine and moderate dose cisplatin) repeated every 21 days for three courses. Mitomycin-C in given with the first and second course only.
Patients responding to treatment or with stable disease are randomised to either:
1. Arm A: Three further cycles of MVP chemotherapy. Mitomycin-C is given with the first and third course only.
2. Arm B: Best supportive care.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Royal Marsden Hospital (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
The Royal Marsden NHS Foundation Trust (UK)
|
|
Address
|
Downs Road
|
|
City/town
|
Sutton
|
|
Zip/Postcode
|
SM2 5PT
|
|
Country
|
United Kingdom
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
20/05/2008
|
|
Date ISRCTN assigned
|
19/08/2002
|
