Condition category
Cancer
Date applied
11/11/2005
Date assigned
24/11/2005
Last edited
03/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mary O'Brien

ORCID ID

Contact details

Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

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 measures

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

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

http://www.royalmarsden.org

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25553247

Publication citations

Additional files

Editorial Notes