| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN49221770 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | L14 |
| 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 |
| Disease/condition/study domain | Lung (non-small cell) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Status of trial | Completed |
| 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 |
| Sponsor name | Royal Marsden Hospital (UK) |
| Sponsor details | Downs Road
Sutton
United Kingdom
SM2 5PT |
| Sponsor telephone | +44 (0)20 8661 3156 |
| Sponsor fax | +44 (0)20 8643 9414 |
| Sponsor website | david.cunningham@rmh.nhs.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN49221770 |
| Date last extracted from ISRCTN register | 17/04/2008 |
