A Randomised Study of MVP (Mitomycin-C, Vinblastine and Moderate Dose Cisplatin) Three versus Six Cycles in Advanced Non-Small Cell Lung Cancer
| ISRCTN | ISRCTN49221770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49221770 |
| Secondary identifying numbers | L14 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 10/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| 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 | Lung (non-small cell) cancer |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mitomycin-C, Vinblastine and Moderate Dose Cisplatin |
| 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 | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
SM2 5PT
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Marsden Hospital (UK)
No information available
Results and Publications
| 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 |
