Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Open, randomised phase III study assessing the toxicity and efficacy of platinum-based chemotherapy with vitamin supplementation in the treatment of lung cancer
Acronym
MVPV1
Study hypothesis
To assess whether the addition of vitamin supplementation to chemotherapy may decrease treatment related toxicity and improve efficacy and outcome
Ethics approval
Approved by the Royal Marsden Hospital, 20/01/2006, ref: 05/Q0801/178
Study design
Open randomised phase III trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung cancer
Intervention
Cisplatin-based chemotherapy +/- vitamin supplementation
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Incidence of neutropenia
2. Incidence of mucositis
3. Incidence of emesis
Secondary outcome measures
1. Disease response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
2. Response rate
3. Overall survival
Overall trial start date
01/01/2006
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Written informed consent
2. Male or female, aged over 18 years
3. Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC), SCLC or mesothelioma: locally advanced or metastatic; where giving cisplatin 75 mg/m^2 is appropriate
4. Eastern Cooperative Oncology Group (ECOG): performance status (PS) zero to two
5. Lab requirements at entry: serum creatinine less that or equal to 1.25 Upper Limit of Normal (ULN), creatinine clearance more than 50 ml/min (Ethylene Diamine Tetra-acetic Acid [EDTA]) or more than 60 ml/min (C+G), white blood cell count (WBC) more than 3 x 10^9/l, neutrophils more than 1.5 x 10^9/l, platelets more than 100 x 10^9/l
6. Presence of at least one bi-dimensionally measurable index lesion
7. Effective contraception if indicated
8. Estimated life expectancy of at least 12 weeks
9. Patients are required to stop all complimentary medicines and prior vitamin supplements
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
84
Participant exclusion criteria
1. Pregnant or lactating women
2. Active infection
3. Inability or unwillingness to take vitamin supplementation
4. Serious systemic disorders incompatible with the study at the discretion of the investigator
Recruitment start date
01/01/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Royal Marsden Hospital (UK)
Sponsor details
Downs Road
Sutton
SM2 5PT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Royal Marsden NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25553247